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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

Are you an experienced IT Project Manager looking for your next big challenge? Want to join a top MedTech company and contribute to meaningful, life-changing innovations? Our client in Hamburg is seeking talented individuals to play a pivotal role in their mission to make a real impact. Don't miss this exciting opportunity! Key Responsibilities: Guide and manage complex IT initiatives in Enterprise Applications, ensuring smooth execution from start to finish Ensure projects are completed on time, within budget, and to the required quality standards Work with senior leadership and stakeholders to define project goals, timelines, and deliverables Adapt project strategies and priorities to address emerging challenges and opportunities Build and maintain strong partnerships with all stakeholders, including business teams, IT departments, and external vendors Lead regular communication sessions to maintain alignment and secure stakeholder commitment Identify potential project risks and implement strategies to minimize their impact on timelines and outcomes Efficiently allocate resources, balancing workloads across teams to meet project goals, ensuring the team is equipped with the skills and tools needed to achieve success Ensure IT projects adhere to healthcare regulations, particularly regarding data security and patient privacy and stay informed of regulatory changes that could affect IT operations Requirements: A degree in Information Technology, Business Administration, or a related discipline Project management certifications such as PMP or IPMA are highly preferred Extensive background in overseeing IT projects within regulated sectors, with a solid grasp of technical requirements In-depth knowledge of business operations and proven experience in optimizing these processes Demonstrated success in leading, motivating, and coordinating diverse project teams in fast-moving, dynamic environments Strong analytical and problem-solving abilities, adept at managing complex, multi-layered projects Exceptional communication and interpersonal skills, with the capacity to influence and collaborate with stakeholders at all levels If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  

Looking for your next challenge in Embedded Systems Engineering?   Passionate about driving innovation in cardiovascular healthcare?   Join our client in Berlin and be a key part of their mission to make a real impact!   Key Responsibilities: Oversee the design, development, and refinement of embedded systems for medical devices, ensuring top-tier reliability, safety, and efficiency • Create and manage embedded firmware and software, including low-level device drivers, real-time operating systems, and communication protocols • Conduct system analysis and debugging to diagnose and resolve intricate issues in embedded systems • Assist in the preparation and review of technical documents such as design specifications, test plans, and user guides • Ensure adherence to medical device regulations, including FDA, ISO, and other industry standards • Perform code reviews and provide technical guidance to junior engineers • Collaborate with cross-functional teams to outline system requirements and ensure they align with project goals • Ensure successful system development and delivery by balancing technical needs, resources, and stakeholder expectations throughout the project’s life cycle • Recruit and manage a team of developers, including both freelancers and full-time employees • Stay informed about emerging technologies and industry trends to enhance existing systems and explore new opportunities   Requirements: A degree in Electronics, Electrical Engineering, or a related field. 7+ years of experience in embedded systems engineering, with significant exposure to medical device development (or another regulated industry) Skilled in embedded C/C++ programming with hands-on experience in real-time operating systems (RTOS) and Linux Strong knowledge of hardware-software integration, including working with microcontrollers, sensors, and communication interfaces Experience with version control tools (e.g., Git) and development environments, including IDEs, debuggers, and CI/CD automation Excellent communication and teamwork skills, capable of working in a multidisciplinary environment Knowledgeable about medical device regulations and standards, such as IEC 62304 and ISO 13485 Experience with safety-critical systems and software development life cycle (SDLC) methodologies is essential     If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.

QA/RA Specialist QA/RA Specialist for a distributor of interventional catheters and products for lipoprotein apheresis in Eschborn, Germany In this role, you will assist with day-to-day QA activities, particularly in the areas of complaint management and change control for medical devices. Apply now to join my client, the European distributor of a leading manufacturer and supplier of innovative life science products. Role Incentives Competitive Salary that reflects your skills and contributions Flexible Working Options with 40% Home Office Individual training & development opportunities Your Key Responsibilities Complaint handling as the designated Complaint Coordinator Change control activities Verification of purchased and non-conforming products Other Responsibilities Maintenance of device registration database Waste management Requirements Completed studies in Natural Sciences/ Engineering Solid knowledge and previous experience working according to MDR and ISO13485 (Certifications good to have) Min. 1 year experience in Quality Management and Regulatory Affairs, ideally in the areas of complaint management, change control, supplier control, CAPA & non-conformities, product registrations and document management Experience conducting/ participating in audits Fluent German & English (required) Reach out to Vivien Zsuzsanna 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  

Development Engineer  We are supporting an innovative client located near Nuremberg, specializing in the field of endoscopic medical devices, in their search for a Development Engineer. This role focuses on the development and optimization of advanced medical products and offers an exciting opportunity to contribute directly to the future of healthcare. The tasks: Lead the development of new and innovative single-use medical products within a structured product development process. Support the creation and maintenance of essential product documentation in compliance with MDR regulations. Plan, conduct, and analyze tests and trials to support ongoing development efforts. Collaborate in the further development and optimization of existing products, components, and manufacturing processes. Your Profile: A Degree in Engineering and experience in product development, particularly with single-use medical devices. Strong knowledge of plastic components and current technologies relevant to the medical device industry. Familiarity with relevant standards and regulatory requirements. Proficiency in CAD software, such as SolidWorks, and excellent project management skills. Strong communication skills in English and German, both written and spoken. Advanced user knowledge of Microsoft Office (Word, Excel, PowerPoint). What’s on Offer: A long-term position in a growing company within the healthcare sector. Responsible and varied tasks with opportunities for professional development. Opportunities for growth through internal and external training. Competitive benefits package, including a company pension scheme and health perks   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

Would you like to drive quality processes for a cutting-edge medical software company?   Are you passionate about contributing to the modernisation and improvement of healthcare?   We're searching for a QMB for our pioneering MedTech client in Munich! Could this be your next step?   Key Responsibilities: Serve as the Quality Management Representative, overseeing all aspects of QMS document management, including creation, revision, and approval processes Lead the CAPA process to ensure timely identification and resolution of non-conformities Coordinate both internal and external audits Provide training and ongoing support to staff on quality-related topics Conduct management reviews to evaluate and report on the compliance and effectiveness of the QMS Draft and evaluate technical documents in line with MDR, regulations for non-EU countries, US FDA 21 CFR Oversee risk management following ISO 14971   Requirements: A degree in Biomedical Engineering or a related field Experience in Quality Management for Medical Devices, including development and/or maintenance of a QMS, as well as participating in internal and external audits Strong knowledge of ISO 13485, MDR, ISO 14971, and standards such as ISO 62304, ISO 62366, Skilled in coordinating processes and providing guidance to colleagues in quality 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.

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