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

Regulatory Affairs Specialist

Regulatory Affairs Spezialist Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Aufgaben Leitung der Implementierung von Qualitätsmanagementsystemkomponenten mit Schwerpunkt auf der Einhaltung regulatorischer Vorschriften, einschließlich MDR 2017/745, ISO 13485 und ISO 14971 Verwaltung von Projekten und Aktivitäten zur Verbesserung von Produkten und Prozessen aus regulatorischer Sicht Kontinuierliche Überwachung und Sicherstellung der Einhaltung regulatorischer Anforderungen, insbesondere in Europa, der Schweiz und dem Vereinigten Königreich Überwachung des Corrective and Preventive Action (CAPA)-Systems, Verfolgung von Rückrufen und Field Safety Corrective Actions (FSCA) zur Behebung von Compliance-Problemen Teilnahme an Risikobewertungsaktivitäten wie uFMEA zur Identifizierung und Verwaltung potenzieller Risiken im Zusammenhang mit unseren Produkten Enge Zusammenarbeit mit dem Quality Director Europe, um sicherzustellen, dass alle Dokumentationen den relevanten regulatorischen Standards entsprechen Unterstützung bei der Untersuchung von Haftungsansprüchen und der Sammlung von Dokumentationen bei Bedarf   Profil 2+ Jahre Berufserfahrung im Bereich Regulatory Affairs oder Qualitätsmanagement im Zusammenhang mit Medizinprodukten Fundierte Kenntnisse der regulatorischen Anforderungen (z. B. MDR, ISO 13485 & ISO 14971) IT-Kenntnisse in MS Office Starke Kommunikationsfähigkeiten, gute Organisationsfähigkeiten, analytisches Denken und ein hohes Maß an Zuverlässigkeit Fließende Englisch- und Deutschkenntnisse sind von Vorteil Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. +49 30 1663 7750   #LI-MC2

Regulatory Affairs Specialist

55,000EUR - 60,000EUR
Regulatory Affairs Specialist Overview With roots dating back to 1930s, our client is dedicated to specializing in high-quality endoscopy products. With them, you can enjoy the personal benefits of creative freedom, collaboration within a collegial team, and the security of our international group structure as well as experience innovation, access tailored training for professional and personal growth, and work in modern, ergonomic spaces with additional perks. Would you like to elevate your career by expanding expertise in technical documentation and regulatory affairs, engaging with a diverse product portfolio? This is your chance! Tasks Seamlessly integrate regulatory requirements and standards into diverse product portfolios, overseeing the creation of product files for technical documentation and independently managing projects Compile international approval documents in accordance with country-specific regulations, collaborating closely with relevant departments to address technical queries Foster trustworthy relationships with customers and suppliers while identifying global regulatory requirements Your profile Apprenticeship or vocational training as an industrial clerk, complemented by additional training and interest in technology and medical products or equiavalent Experience in MedTech industry or in areas such as Regulatory Affairs, Quality Management, Technical Documentation, Sales or Development Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) 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  

RAQM Engineer

60,000EUR - 80,000EUR
Regulatory Quality Engineer Join a world-leading company in MedTech, who are working in the field of cancer detection & treatment, as they search for a new team member to support the Quality & Regulatory Affairs activities. You will join a strong team, have varied and interesting projects, and support with the following tasks: Responsibilities: • Coordinating, executing, and endorsing international regulatory product clearances and registrations  • Compiling documentation and approval dossiers for new items while keeping in mind applicable laws and guidelines • Assisting development teams in making sure pertinent standards are followed • Assist with engineering and service teams in all quality-related matters • Assist with process and product enhancements • Upkeep and future advancement of the QM system • You have a great deal of freedom to reshape the environment, become involved in new areas, alter processes, and bring new approaches Experience required: A degree in the medical or scientific field (or equivalent) 3-5 years of experience in Regulatory Affairs and/or Quality Management in the medical technology field Ideally, you bring experience with active medical devices or medical software Fluency in English and German Knowledge of regulatory requirements and medical device relevant standards (e.g. ISO 13485, EU-MDR, ISO 14971) If you're interested in this position, please apply here and/or contact Hollie Dear for further details: #LI-HB1  #LI-Hybrid

Senior Regulatory Affairs Manager

70,000 - 90,000 depending on experience
(Senior) Regulatory Affairs Manager Are you interested in joining an award-winning company who are innovating in the field of cardiotherapy? Want to be a part of a collaborative team and work on diverse projects in Regulatory Affairs? 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 Regulatory Affairs function. Could you be their new Senior Regulatory Affairs Manager? * This is a hybrid position, so you must be accessible to the site. Focuses: Overseeing product registrations in national and international markets Supporting with determination of regulatory strategies Support with successful entrance of products into new markets Providing support during internal and external audits Communication with regulatory authorities and Notified Bodies Optimisation of approval processes Experience required: 5+ years of experience within Regulatory Affairs for medical devices Strong knowledge of EU regulations and guidelines Project management experience is desirable Fluency in English and German You will get: Home office flexibility Kindergarten allowance Travel allowance Wellness incentives e.g. in-house company gym, sports groups If you're interested in this position, please contact Hollie Dear for further details: #LI-HB1 #LI-Hybrid

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!