Regulatory Affairs

Head of Quality & Regulatory Affairs (m/f/d)   Location: Tuttlingen, Germany (Hybrid)   Overview:   Our client has been manufacturing innovative medical devices for over 20 years and has over 150+ employees.   Benefits: Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Holiday & Christmas Bonus + Pension Scheme Flexible Work Options: Take advantage of the opportunity work from home 2 days per week + Flexible working hours Generous Vacation Policy: 31-days vacation including 1 day off for your birthday. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work. Permanent Full-Time Position: Permanent employment in a growing company with secure future prospects. Continuous Evolution & Development: Wide range of development opportunities Responsible and varied tasks working in a fun and diverse team, being responsible for the compliance department Flat hierarchies and short decision-making processes enable you to achieve a lo   Tasks:   Leadership & Strategy   Head of the Compliance Department with a focus on Regulatory Affairs, Quality Management and Quality Assurance Determination of the certification strategy: Medical devices/UL 8139/Drug-Device-Combination, etc.   Product Conformity & Approvals   Responsibility for all product approvals and their maintenance in cooperation with internal and external bodies Ensuring compliance with standard requirements in close cooperation with R&D Assessment and release of technical documentation for medical devices of risk classes I-III under the MDR   Risk Management   Responsibility for conducting risk assessments for our medical devices (electrical devices & associated software) Intensive cooperation with R&D in defining risk-minimizing measures Management of periodic reviews regarding risk assessments     Your Profile:   Successfully completed degree - ideally with a technical focus (preferably with a doctorate) 7+ years of professional and project experience in the specified field of responsibility High problem-solving skills and analytical skills to identify and proactively manage complex (partly technical) challenges Leadership experience (3+ years) A high level of communication skills and enjoyment of working together across interfaces Knowledge of quality management and approval of medical devices (ISO 13485, MDR, FDA, etc.) Ideally, experience in conducting clinical trials You have very good German and fluent English skills, both written and spoken Experience working in an international environment     To apply or for more information, please get in touch with Luke Fines by email at: luke.fines@adaptivelifescience.com

Senior Regulatory Affairs Manager (m/f/d) Location: Germany (Remote) Overview: Our client is a registered CRO (clinical research organisation); however, their support and services go beyond those of a typical CRO. The team are specialists in the area of medical device approval and market observation. Benefits:   Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Flexible Work Options: Take advantage of a fully remote, home office position with flexible working hours. Generous Vacation Policy: 30-days’ vacation. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work. Permanent Full-Time Position: Permanent employment in a growing company with secure prospects. Continuous Evolution & Development: Wide range of development opportunities, including the possibility of team leadership Responsible and varied tasks working in a fun and diverse team that works with a diverse range of customers with different challenges and requirements. Learning Opportunities; benefit from seminars and other educational opportunities. Tasks:   You create and update the technical documentation of medical devices according to Annex II and III of the MDR You carry out market surveillance (Post-Market Clinical Follow-up, PMS) in accordance with MDR You carry out PMCF activities Your Profile:   You have at least four years of professional experience in regulatory affairs for medical devices You have a degree in mechanical engineering, electrical engineering or medical engineering or a comparable qualification such as a scientific degree or you have at least 10 years of professional experience in the field of regulatory affairs for medical devices You have experience in the approval of medical devices, especially software as a medical device You have good knowledge of MDR and FDA requirements as well as quality management Good knowledge of IEC 62304 You are a team player and have strong communication skills You are ready to familiarize yourself with new topics and areas You have very good German skills (C2 level) and good English skills (at least C1 level) To apply or for more information, please get in touch with Luke Fines by email with a copy of your CV at: luke.fines@adaptivelifescience.com           

Are you an experienced Technical Writer looking to make an impact in the medical field? Do you want to create clear, accurate documentation that supports both product development and user training for life-saving medical devices? Join a dynamic team and contribute to the success of cutting-edge medical products! Key Responsibilities: Develop comprehensive documentation for technical products, including user manuals, guides, and technical specifications. Collaborate with engineers, product developers, and other stakeholders to ensure accuracy and consistency. Edit and revise existing content for clarity, consistency, and compliance with standards. Ensure all documentation meets regulatory and compliance requirements. Requirements: Bachelor's degree in Biomedical Engineering, or a related field. At least 3 years of experience in technical writing within the medical device industry, including instructions for use, patient brochures etc. Excellent written communication skills and the ability to simplify complex concepts. Familiarity with regulatory standards for medical devices. 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 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

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

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