Regulatory Affairs
Our team here at Adaptive Life Science understand the importance having a strong product management team in place.
We are constantly networking, speaking to and building relationships with the top Product Leaders, Product Owners/Manager, Scrum Masters & Agile Coaches, as well as UX/UI-Designers and other Product Experts.
Our specialist focus in the MedTech sector means that all of our client and candidate relationships are with traditional medical devices and/or digital health products.
We understand the importance of cultural fit and communication style for product teams, and take this into high consideration when matching professionals in this space with possible companies.
Traditional Medical Devices
Adaptive’s highly experienced consultants have grown an extensive network of top professionals and medical device manufacturers.
We support product professionals with experience in all areas of the Medial Device space including Class I – III products, IVDs, Software, Invasive and Non-Invasive Devices, as well as Prosthetics and Implants.
Digital Health
The Digital Heath Sector is one of the fastest growing sectors within Healthcare, if not the fastest, and the global pandemic has only helped accelerate it.
Whether it’s a DiGA, new product coming to market, device utilizing AI or VR, we know them all and the companies offering innovation and creative freedom.
From VC backed start-ups to global players entering the digital health space, we have options to suit your style and product interests.
For our clients in digital health, we’re in contact with professionals across the wide spectrum of product management, from technical (with a track record of managing product development and design, including the planning process) to UX/UI, product growth and owners responsible for an entire app.
Active jobs
Head of Regulatory Affairs
Geneva
Switzerland
Depending on Experience
Head of Regulatory Affairs
Location: Geneva, Switzerland
Our client, a leading innovator in the design and manufacturing of combination MedTech products with a broad and ever-growing product portfolio, is seeking a Head of Regulatory Affairs to manage the EMEA & US operations and provide strategic input to the executive leadership team. This role involves overseeing the full life cycle of new and existing products.
Main Responsibilities:
Develop and implement regulatory strategies aligned with business objectives, supporting pre and post market projects and influencing across TechOps to drive urgency
Oversee regulatory submissions and ensure compliance with EU & US standards
Monitor regulatory changes and adapt strategies accordingly
Collaborate with cross-functional teams on new product development
Mentor and lead the Regulatory Affairs team and manage regulatory responses and ensure effective team communication
Support QMS optimization and continuous improvement – key partner for Quality Operations
Requirements and Skills:
10+ years of experience in Regulatory Affairs within Medical Technology / Combination Products with pre and post market exposure.
Relevant education and experience to act as PRRC an advantage.
Extensive knowledge of EU regulations and experience negotiating with regulatory agencies and Notified Bodies (FDA experience a plus)
Proven leadership abilities, including team management experience, mentorship, and strong decision-making skills – strong communicator with the gravitas to deal with multiple internal and external stakeholders
Strategic thinking and the ability to thrive in a dynamic, fast-paced environment
Fluent in English, French a plus
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Etienne van Wyk for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
etienne.vanwyk@adaptivelifescience.com
#LI-EV1
Regulatory Affairs Manager
Stuttgart
Germany
€60,000 - €75,000 DOE
Would you like to drive international approvals for a market-leading medical device company?
Are you interested in working with innovative biomaterial products?
We're searching for a Regulatory Affairs Manager for our client in the Stuttgart area!
Key Responsibilities:
Developing and maintaining technical documentation
Managing international regulatory approvals, particularly in the USA, including strategy, coordination, preparation, and submission.
Assisting distributors with regulatory matters
Handling communication with regulatory authorities
Conducting Post-Market Surveillance through database research, trend analysis, evaluation, and reporting
Investigating and reporting incidents and Field Safety Corrective Actions (FSCAs).
Overseeing change management and process improvements
Requirements:
A degree in Biomedical Engineering, Medical Technology, or a related field
Good experience in the regulated medical device industry (ISO 13485, ISO 14971, MDD, MDR, QSR, MDSAP)
Expertise in obtaining medical device approvals, particularly for the US FDA market.
You enjoy handling cross-functional department communication and advising on regulatory affairs topics
Fluency in German and English
If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.
Head of Department – Quality Management & Regulatory Affairs
Aachen
Germany
€90,000 - €100,000 DOE
Head of Department - Quality Management System & Regulatory Affairs
Location: Aachen
We are supporting a client in the MedTech industry, specializing in the development and manufacturing of innovative medical devices, in their search for a Head of Quality Management System & Regulatory Affairs. In this role, you will lead a dynamic team, overseeing quality management and regulatory processes to ensure compliance and drive continuous improvement.
Key Responsibilities:
Lead an interdisciplinary team of experts, fostering a culture of continuous improvement and quality.
Manage the company’s Quality Management System (QMS) in compliance with international standards (ISO 13485, EU MDR, FDA), and ensure regulatory approvals for medical devices in global markets.
Oversee risk management strategies and ensure the successful planning, execution, and follow-up of internal/external audits and inspections.
Collaborate with cross-functional teams in product development, production, and marketing to ensure smooth product launches.
Monitor trends in regulatory standards and integrate them into the company's strategic planning.
Improve operational efficiency through the integration of automated software systems, enhancing transparency and regulatory compliance.
Your Profile:
Degree in medical technology, engineering, natural sciences, or a related field.
Several years of experience in quality management and regulatory affairs within the medical device industry.
Strong knowledge of ISO 13485, EU MDR, and FDA regulations.
Proven leadership skills with experience managing and developing teams.
Exceptional organizational, communication, and project management skills.
Fluency in German and English (both written and spoken) is essential.
This position offers the opportunity to lead a key department within a cutting-edge MedTech company, with a focus on driving innovation while maintaining the highest regulatory standards.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
Senior Regulatory Affairs Manager
Freiburg im Breisgau
Germany
€70,000 - €100,000 DOE
Are you a Regulatory Affairs professional in the medical technology field, looking for a new opportunity?
Would you like to support the international market access of high-risk, complex medical devices?
We're currently supporting a client in the medical device industry who are located in Freiburg and looking to strengthen their team.
Key Responsibilities:
Prepare and compile regulatory submissions for new medical device registrations and updates to existing products in compliance with regulations
Oversee the successful approval of Class III medical devices for the European and US markets (MDR and FDA regulations)
Monitor new legislation, policies, standards, and guidelines
Perform post-market surveillance and report any adverse events or field safety corrective actions
Overseeing engineering changes, product labelling, and promotional materials
Requirements:
A degree in Biomedical Engineering, Life Sciences, or a related field
At least 3-5 years of experience in regulatory affairs/international product approvals
Comprehensive understanding of MDR/FDA requirements and associated guidelines
Fluency in German and English
If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.
Senior Quality & Regulatory Affairs Manager
Munich
Germany
Circa €70,000 DOE
Senior Quality and Regulatory Affairs Manager
Our client is seeking an experienced and motivated Senior Quality and Regulatory Affairs Manager to join their fast-growing medical device company in Munich, Germany.
In this role, you will play a crucial part in maintaining global quality and regulatory compliance. You'll have the opportunity to collaborate with internal teams, mentor junior staff, and manage important relationships with regulatory authorities and external partners.
Key Responsibilities:
Manage and maintain technical documentation for product submissions, changes, and quality management (QM)-related documents.
Mentor and train staff across various departments to ensure effective execution of regulatory responsibilities.
Conduct compliance audits, including assessments of vendors, clients, and subcontractors.
Support and manage external audits with notified bodies and competent authorities, overseeing risk management and post-market surveillance activities.
Oversee the establishment, maintenance, and optimization of Quality Systems to ensure full regulatory compliance..
Act as a primary contact for regulatory agencies, assisting with negotiations and managing interactions during inspections and audits.
Key Qualifications:
Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree or MBA preferred).
Minimum of 4 years of experience in quality management and regulatory affairs within the medical device industry.
Proven experience with regulatory submissions and approvals such as MDD/MDR.
Experience with regulatory audits and a deep understanding of medical device standards.
Flexible, goal-driven, and a collaborative team player focused on delivering results.
This role offers a unique opportunity to contribute to a growing company and shape the development of cutting-edge medical technologies aimed at improving patient care.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
#LI-Hybrid
Regulatory Affairs Professional
Freiburg
Germany
€60,000 - €70,000 DOE
Regulatory Affairs Professional
Location: Freiburg, hybrid flexibility
Are you ready to ensure groundbreaking medical products reach global markets by navigating regulatory challenges?
As a Regulatory Affairs Professional, you will play a critical role in ensuring that IVD products meet all regulatory requirements for international markets. Collaborating closely with the quality management team, you will develop and implement approval strategies, prepare and submit regulatory documentation, and act as a key contact for regulatory authorities.
Your tasks:
Develop and implement regulatory strategies in collaboration with quality management.
Stay updated on regulatory changes and ensure compliance with international norms and standards.
Prepare, review, and adapt approval-relevant documents, including technical documentation.
Submit marketing authorization documents and manage product registrations with relevant authorities.
Monitor and maintain compliance with applicable norms and standards.
Initiate corrective and preventive actions in response to quality-related issues.
What is required:
A university degree or relevant professional experience (2+ years) in Regulatory Affairs.
In-depth knowledge of IVDR and IVDD, with familiarity with other international regulations and approval procedures.
Fluency in both German and English, with excellent written and verbal communication skills.
Strong attention to detail and quality awareness.
What is offered:
Flexible working hours and mobile working options.
Ongoing training and personal development opportunities with a dedicated training budget.
Regular team events and a supportive, motivated team environment.
A dynamic work environment where you can actively contribute to shaping the company's structure and goals.
If you're passionate about regulatory affairs and thrive on navigating complex compliance landscapes, I would love to hear from you.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
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If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
#LI-Hybrid
Regulatory Affairs Specialist
Halle
Germany
Flexible, depending on experience
Are you looking for your next step in Regulatory Affairs?
Interested in joining a leading European company that supports some of the world’s most respected brands?
We're currently supporting a client in the packaging technology field who are growing their team in Regulatory Affairs.
Key Responsibilities:
Conduct comprehensive reviews and evaluations of relevant laws, regulations, guidelines, and standards in Germany and the EU concerning consumer goods.
Acquire, scrutinize, and manage declarations of conformity and supplementary declarations on raw materials from suppliers.
Maintain the compliance system to ensure adherence to food laws.
Draft and update declarations of conformity in line with consumer goods legislation.
Address customer and regulatory inquiries, serving as the primary contact within the Coveris Flexibles Group in Germany for all matters related to food and consumer goods law.
Evaluate and approve new raw materials.
Assist in the development of new products by providing guidance on regulatory matters.
Requirements:
A degree in food chemistry, food technology, or packaging technology.
In-depth knowledge of consumer goods and food law within Germany and the EU.
A strong sense of responsibility and a commitment to high-quality standards in compliance with legislation.
Excellent communication skills.
Proficiency in German and English.
If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information.
Head of Regulatory Affairs (Europe & USA)
Geneva
Switzerland
150,000 - 170,000 CHF
Head of Regulatory Affairs
Location: On-site in Geneva, Switzerland
Our client, a leading innovator in the design and manufacturing of combination medical device products is seeking a Head of Regulatory Affairs. This role involves overseeing the EMEA and US regulatory teams dedicated to Innovation and Life-Cycle projects.
Main Responsibilities:
Develop and implement regulatory strategies aligned with business objectives.
Oversee regulatory submissions and ensure compliance with EU & US standards.
Monitor regulatory changes and adapt strategies accordingly.
Collaborate with cross-functional teams on new product development.
Mentor and lead the Regulatory Affairs team.
Manage regulatory responses and ensure effective team communication.
Support QMS optimization and continuous improvement.
Requirements and Skills:
Minimum 10 years of experience in regulatory affairs within Medical Technology
Extensive knowledge of EU regulations and experience negotiating with regulatory agencies and Notified Bodies.
Proven leadership abilities, including team management experience, mentorship, and strong decision-making skills.
Strategic thinking and the ability to thrive in a dynamic environment.
Diploma and experience to act as Deputy PRRC.
Fluency in English
Good level of French language preferred.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
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Read our Blogs
19. 06. 2023
Why Companies Should Choose Adaptive Life Science for Their Specialized Life Science Recruitment Needs
In the dynamic and ground-breaking field of Life Sciences, finding world-class talent is essential for the success of medical companies. That's where Adaptive Life Science comes in. As a specialized recruitment agency, we provide tailored services to the Life Science sector, covering the Medical Device, Diagnostic, and BioTech industries globally. In this article, we will explore the unique advantages of partnering with Adaptive Life Science and why we’re the ideal choice for your specialized Life Science recruitment needs.
Expertise in Life Science Sector
At Adaptive Life Science, we specialize in understanding the intricacies of the Life Science sector. Our team possess in-depth knowledge of the Medical Device, Diagnostic, and BioTech industries. We stay updated with the latest advancements, regulatory requirements, and industry trends within these sectors. You’ll meet us at major conferences across the world, and we’re also a member of RAPS. This expertise allows us to identify and connect with top talent who possess the specialized skills and experience required for the specific needs of manufacturers and OEMs. By partnering with Adaptive Life Science, you gain access to professionals who understand the complexities of the Life Science sector and can contribute to the innovation and growth of your organization.
Global Reach and Network
With a global reach and extensive network, Adaptive Life Science is well-positioned to serve medical device, biotech, and pharmaceutical l companies around the world. We have established connections with leading professionals and organizations within the Life Science sector. Our network spans across geographies from our global offices, allowing us to access talent from various regions and markets. Whether you require expertise in research and development, regulatory affairs, clinical trials, quality assurance, or other specialized areas, Adaptive Life Science can tap into its global network to find the most innovative and qualified candidates for your organization. We understand the global nature of the Life Science industry and can support your recruitment needs locally or internationally.
Tailored Recruitment Solutions
At Adaptive Life Science, we recognize that every medical company has unique recruitment requirements. We offer tailored recruitment solutions to meet your specific needs. Our process begins with a comprehensive understanding of your organization, its culture, and the specific roles you are looking to fill. We then leverage our industry expertise and network to identify candidates who possess the necessary skills, experience, and cultural fit. Our tailored approach ensures that we connect you with candidates who align with your organization's vision and goals, setting the stage for long-term success.
Try the experts
Partnering with Adaptive Life Science for your specialized Life Science recruitment needs offers distinct advantages.
With our expertise in the Life Science sector, global reach and network, and tailored recruitment solutions, we are the ideal partner to connect you with industry leading talent across Medical Device, Diagnostic, and BioTech industries, if you are a scaling start-up, mid-sized company, or global player. By leveraging our industry knowledge and extensive network, you gain access to professionals who possess the specialized skills and experience required to drive innovation and process excellence within your company.
Come and experience the difference in finding exceptional talent that propels your organization's growth and success in the dynamic Life Science field.
Why not reach out today for an open chat about the market and how Adaptive Life Science can support your growth.
04. 01. 2023
Medical Device Companies Near Me - Thinking About A Change?
Being happy at your workplace is crucial for your mental health. It not only impacts your happiness, but also your overall performance. So, how do you know that it is time to move on and find a new job?
Signs that show you could be ready for a career change:You are being overworked – You need a work/life balance, not being able to switch off can be dangerous and could result in constant stress and issues with sleeping. Not being listened to – You do not feel like you are recognized, your ideas are often shut down and overlooked. This can easily demotivate anyone and as result make us stop caring! Your opinion matters and you should be encouraged to share your thoughts.You have lost the satisfaction of what you do – Work has become a chore and when you arrive back home, you are feeling unfulfilled.Your salary is not increasing – You feel like you are being given many new tasks and the salary does not match the work involved. Talks about a pay rise are being ignored.You are not developing any more – No potential to grow within the company, learn anything new or to have additional responsibilities.Toxic manager/environment – You dread going to work and feel stressed whenever you are there. The atmosphere at work is very important and plays a big role in how you perform and feel at your workplace. Every job can have its ups and downs. There will be obstacles you need to overcome to become better at what you do; however, it should also be filled with many fun moments and reasons that make you enjoy going to work! If it is not making you happy anymore, you feel like it has nothing else to offer and it is affecting your health and personal life then perhaps it is time to think about the change. It is never easy to make this decision, but life is too short to settle for less than you deserve!
16. 06. 2022
Navigating Difficult Conversations at Work
Dealing with conflict or tough conversations at work. It’s comparable to the ‘we need to talk’ dread all of us have undoubtedly faced at some point in our personal lives.Whether it’s addressing distracting behaviours in the office, challenging your colleague on the accuracy of a report or confronting a long-overdue company problem – these conversations need to happen, and they need to happen for a few reasons:- The problem can’t be fixed if there is no awareness of the problem in the first place.- Get that weight off your shoulders, its liberating!- It’s how we achieve professional and personal growth – your company will benefit from this too. The art of conversation is like any art. With continued practice you will acquire skill and ease.Finding the right words, and the right moment – it is no easy task in the fast-paced commercial world. Step 1) Conquer your fears and just do it.Here are some tips to make the conversation easier…Set a Positive Tone - Mindset matters. Frame the conversation in a different way and put a positive spin on it. Be constructive, not negative. Can you offer an alternative solution to the one currently on the table? Make sure there is an action plan in place when a consensus (or even just an understanding) is reached to ensure you move forward.Keep Your Cool- Don’t forget to breathe! Taking this brief moment to focus on your breathing will allow you to refocus and absorb any information. It’s important that whether you are the recipient or provider of a challenging discussion, that you make a conscious effort to slow down the pace of the conversation, listen, collect your thoughts, and respond rationally.Plan with Emotional Intelligence- Think ahead. What do you anticipate the response will be to the discussion? Put yourself in the shoes of your counterpart to mentally consider their possible responses. You can have some flexible strategies to hand on how to move the conversation forward in a productive way. If you don’t feel confident on the recipients view beforehand, ask them.Be Concise and Direct- Difficult conversations need to be clear and to the point, otherwise the message gets lost in a muddled delivery. To avoid receiving objections, be prepared with concrete examples. Focus on facts, not feelings. Try not to let your emotions get the better of you when you are trying to find a resolution.Make It a Conversation- Feedback shouldn’t be a monologue - there should be two-way communication. Make sure there is an opportunity for an open discussion and questions to allow the meeting to end with unwavering clarity on both sides. Do you fully understand each other and what will happen next? “Difficulties are meant to rouse, not discourage. The human spirit is to grow strong by conflict.”- William Ellery Channing, American Theologian