Regulatory Affairs

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.  

Are you passionate about ensuring safety and quality?   Do you enjoy navigating regulatory standards and managing product compliance?   Join our innovative client and play a crucial role in ensuring their devices meet all regulatory requirements and safety standards.   This position is ideal for someone with an engineering background, with a solid understanding of regulatory requirements who thrives in a detail-oriented, cross-functional environment!   Key Responsibilities: Identify and interpret compliance standards for our products. Assess standard updates and determine necessary adjustments with relevant departments. Develop product specifications for new products based on industry standards. Oversee approvals and maintain certifications by collaborating with both internal teams and external authorities. Work closely with certification agencies (e.g., UL, TÜV) to meet industry requirements. Plan, coordinate, and conduct risk assessments for our medical devices (including electronic components and software). Support product development in defining and validating risk-reducing measures. Schedule and perform routine reviews of risk assessments.   Requirements: Bachelor's degree in Engineering e.g. Electrical Engineering or equivalent technical training with relevant professional experience. Familiarity with regulatory requirements for medical devices or electronic appliances. Excellent communicator and team player who enjoys interfacing between development and regulatory compliance. 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.

Quality Management and Regulatory Affairs Group Lead Quality Management and Regulatory Affairs Group Lead for a medical device & chemical product manufacturer in Lorsch, Germany In this role, you will for managing the Quality and Regulatory Departments and ensure product quality and regulatory compliance by maintaining certifications, managing technical documentation and overseeing the Quality Management System (QMS). Apply now to join our client, a leading manufacturer known for its innovative solutions and exceptional customer service with a deep focus on sustainability in product development. Role Incentives An inspiring working environment where your ideas count Competitive Salary First-class development opportunities Flexible working Your Key Responsibilities Maintain the marketability of all products by verifying compliance with customer specifications and regulatory requirements Monitor and maintain technical documentation in accordance with legal requirements Oversee and improve the quality management system (QMS) to ensure compliance with regulatory standards Ensure adherence to the QM system and internal processes, including project management and implementation of quality policies and objectives Other Responsibilities Lead group management and team building Contribute to the development and execution of the overall corporate strategy Represent the company in external communications with authorities and regulatory bodies Requirements Relevant degree in Life Sciences, Engineering, Quality Management, or related field Minimum 5 years of experience in quality and regulatory compliance within BioTech/MedTech/Pharmaceutical sectors Strong knowledge of ISO 13485, GMP, and MDD/MDR standards, with expertise in quality assurance, compliance, and market authorization processes Proven skills in building and improving Quality Management Systems Structured, independent leader with experience in team management, project oversight, and cross-functional collaboration. Fluency in German and English Knowledge of other relevant standards e.g. BPD/BPR, Cosmetics Regulation, German manufacturing authorization are a plus! Reach out to Vivien Urban for more information about the company culture, and long-term development plans. 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 Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   Vivien.urban@adaptivelifescience.com +49 30 16639819  #LI-VU1  

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