Regulatory Affairs

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

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 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

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 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 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. ??????? 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  

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  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