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

Risk Manager

65,000EUR - 75,000EUR
Are you interested in joining a dynamic company who are innovating in the cardiovascular field? Would you like to have a major impact on the successful market delivery of medical devices and transform treatment options for patients? We're currently supporting a client in the medical device industry who are headquartered in Munich and are looking to strengthen their team. Responsibilities: Initiate, maintain, and update the risk management process in compliance with ISO 14971, 21 CFR820, and other relevant standards. Develop, maintain, and update all documents within the risk management file, including risk management plans, FMEAs, annual reports, and more. Coordinate and oversee all risk management activities with cross-functional teams.. Contribute to the assessment of customer feedback and risk evaluation, analysing quality issues, complaints, incidents, and proposed changes related to known and potential new risks. Prepare all risk-related documents for the technical file, such as risk-benefit analyses. Support and plan product Design Verification and Validation activities. Requirements and Skills: Bachelor’s degree in Engineering or a related field. 3+ years of experience in risk management of medical devices in accordance with ISO 14971, ideally for class II or III devices. Proficiency in technical, regulatory, and medical writing, with experience in drafting technical reports.  Fluency in English, German is a bonus. Experience working with regulatory bodies and competent authorities. Basic understanding of regulatory requirements for medical devices, particularly MDR and 21 CFR820. If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  

Regulatory Affairs Manager

60,000EUR - 70,000EUR
Regulatory Affairs Officer Overview Are you looking for a new challenge in regulatory affairs? I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971. This is a hybrid working position where you can work 2/3 days from home. Tasks Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1 Support international distributors in the approval process of the medical devices PMS activities such as PMS files and vigilance investigations Your profile Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) IT Skills such as MS Office Good communication and organizational skills as well as independence and reliability Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 1663 7750 #LI-MC2  

Senior Vigilance and PMS Specialist

70,000EUR - 85,000EUR
Senior PMS & Vigilance Specialist Are you a competitive spirit, looking for the next challenge to conquer? Do you believe that effective teamwork can propel you further than you could ever go by yourself? Are you looking for a future-proof workplace where personal and appreciative cooperation is at the core of your employer’s mission? Look no further… Overview: My client is an industry leader in orthopaedic product development and medical education. They are dedicated to delivering top-quality solutions for healthcare professionals and the countless patients benefiting from their devices. Tasks: Creation and submission of vigilance reports in the EMEA region Assessment of potentially reportable incidents Processing product complaints, monitoring and coordinating further processes Handling FSCAs Participating in internal and external audits Your Profile: Degree in a scientific, medical or technical field or comparable qualification Experience working with medical devices or similarly regulated products Sound knowledge of handling customer complaints and reportable events per MDR Knowledge of additional international medical device regulatory frameworks are a plus! (e.g. FDA, MDSAP etc.) Fluent written and spoken German and English are a must! Interested?  Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 16639819 #LI-VU1  

Medical Affairs Director/Senior Manager

70,000EUR - 90,000EUR
Medical Affairs Director/Senior Manager Are you an expert in Medical/Clinical Affairs in Class III Implantable Devices? Are you looking to take your next step into a leadership role? Do you want to work with a global technology leader in regenerative medicine? We are currently supporting our client headquartered in Germany to strengthen their clinical/medical affairs function. This is a remote role, so you can be based anywhere in Germany but must be willing to travel from time to time. Does this sound like your next career step? Tasks Management of a small team (2-5 employees) Ensure regulatory compliance for clinical trials and medical products on the market in accordance to MDR, TGA and FDA Pre-market and post-market clinical projects, including medical writing, CERs, PMS, and PMCFs Clinical trial project management (documentation, budget planning, collaboration with stakeholders on an international level as well as CROs) Reimbursement and compliance (Europe, especially Germany) Your profile Degree in a scientific field such as biomedical, biology, medicine, medical engineering or a comparable field of study Experience in clinical (e.g. CER), regulatory affairs, bio-medical publication or medical writing, especially for class III implants Strong communication skills and project management experience Team player who can also work independently Knowledgeable in MS Office Fluency in English, German is a bonus Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 1663 7750 #LI-MC2  

Senior Clinical Affairs Specialist

65,000EUR - 80,000EUR depeding on experience
Senior Clinical Affairs Specialist Are you interested in joining an award-winning company who are innovating in the field of cardiotherapy? Are you experienced with pre-market and post-market clinical studies for active medical devices up to class III? We're currently supporting a client in the medical device industry who are head-quartered just outside of Munich and are looking to strengthen their Clinical Affairs function. This is a hybrid position, so you must be accessible to the site. Could you be their new Senior Clinical Affairs Specialist? Tasks Responsible for the strategy and execution of clinical evaluation for medical devices up to Class III Look after the conception and the evaluation of follow-up studies Collaborate with clinical partners for various research projects Provide scientific input while supporting other areas of the organization Provide mentorship and sharing your expertise with colleagues Your profile Degree in a technical or scientific field, ideally in the direction of medical technology Several years of experience in clinical evaluation and follow-up of active medical devices up to class III Solid foundational knowledge of relevant regulatory and normative requirements (MDR, ISO 14155, MDCG Guidance etc.) Team player who can also work independently Eager to learn attitude and willingness to share your knowledge Fluency in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 1663 7750 #LI-MC2  

Regulatory Affairs Specialist

Regulatory Affairs Specialist Are you passionate about bringing safe and effective medical devices to market with speed and agility? My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team. Ready to put your skills to work? Your Tasks: Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971 Manage projects and activities for the improvement of products and processes from a regulatory standpoint Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK) Manage CAPA system, track recalls and FSCAs Participate in risk assessment activities such as UFMEA Collaborate with the Quality Director Europe to ensure documentation is compliant Assist in liability claim investigation and document collection Your profile: Fluent in English and at least intermediate knowledge of German 2+ years professional experience in regulatory affairs or quality management relating to medical devices Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971) Computer proficiency with MS Office Strong communication skills, good organizational skills, analytical thinking and a high level of reliability Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 16639819 #LI-VU1

Senior RA Specialist

60,000EUR - 70,000EUR
Senior Regulatory Affairs Specialist Location:   Would you like to work for a global healthcare leader in point of care diagnostics?  We are currently supporting our client who is looking for a Senior Regulatory Affairs Specialist to join their Diagnostics Division in Jena, Germany. Your tasks: Preparing and submitting technical files and communications to the Notified Body and regulatory agencies Supporting the regulatory department for efficient and compliant business processes Contributing to process/product improvement projects and risk management Assisting with label development and review for compliance Building strong relationships with internal and external stakeholders Your profile: Bachelor’s degree (BA/BS) from an accredited University Minimum of 2 years experience working in Regulatory Affairs with medical devices (e.g. with MDR or IVDR) Strong communication skills in English and German Strong attention to detail and a positive, flexible mindset Team player, preferably with experience in project- and team management Basic understanding of IVD regulation and experience generating quality documentation is a plus! Benefits: Meaningful Impact: contribute to improving patient well-being Career Growth: international opportunities in a fast-growing industry Attractive Benefits: comprehensive package including pension and stock options Global Recognition: join a globally recognized, diverse, and inclusive workplace Collaborative Environment: work with a dynamic, skilled team in an open and efficient culture If you feel this role was made for you, apply with your CV or contact Vivien Urban for further details or additional vacancies in the MedTech industry. No CV? No problem - you can leverage your LinkedIn profile instead. #LI-VU1

Risk Manager

60,000EUR - 80,000EUR
Risk Manager Location: Frankfurt area (high degree of remote flexibility) Would you like to work for a global leader in the treatment of renal disease and support the safety of the product through a risk management process? We are currently supporting our client who is looking for a Risk Manager to join their Product Development Team. Your tasks: Plan and execute the risk management process. Create risk assessments for complaints and support the preparation of FMEAs. Support the audit of design & development and risk management sessions. Create and monitor the design control metrics in development, post-market activities, and change management. Monitor the state of the art to continuously improve product safety. Responsible for pre-production defect management (Anomaly Reports), risk analysis, and specification of countermeasures. Your profile: A degree in engineering, biology, medical technology, or equivalent. Minimum of 3 years of experience in Regulatory Affairs, Research and Development, or Risk Management. Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.) High degree of knowledge in FMEA method, and quality management and risk management standards (ISO 13485 and ISO 14971). Fluent in written and spoken English and advantage of German skills. Benefits: Very international environment. High home office flexibility and flexible working hours. Continuous support in the development. Pension scheme. Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. #LI-DW1 #LI-Remote

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.
25. 05. 2023

Relocation – why it can come with benefits and growth when it’s done right

Relocation and its benefits are a huge topic within recruitment, especially when speaking about niche industries like: MedTech, Aviation and Aerospace, or Mining.
04. 01. 2023

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!