Clinical Regulatary Affairs Manager

Clinical Regulatory Affairs Manager

Location: Near Munich, mainly on-site 

Are you ready to take your regulatory expertise to the next level and contribute to life-saving innovations in the cardiovascular field?

We are supporting a growing company in the cardiovascular sector in their mission to bring cutting-edge medical technology to market. In this role, you’ll play a key part in securing CE mark approval for a Class III medical device, collaborating with cross-functional teams and ensuring global regulatory compliance.

Key Responsibilities:

• Support the Director of Regulatory Affairs in driving CE marking approval and shaping global regulatory strategies in line with EU MDR, FDA, and international standards.
• Prepare and submit the technical file to the European notified body, ensuring compliance with all regulatory requirements.
• Collaborate with R&D, Quality, and Clinical teams to gather and review essential documentation for regulatory submissions.
• Monitor and report safety and vigilance data to maintain compliance and patient safety.

Requirements:

• Minimum 3 years of experience in writing and reviewing regulatory documentation and CE Mark submissions under EU MDR.
• Strong experience with EU MDR and CE mark submission.
• Knowledge of FDA regulations is required; IDE submission experience is an advantage.
• Experience in regulatory affairs within the medical device industry, ideally with Class III devices.
• Ability to work cross-functionally and manage complex documentation for regulatory submissions.
• Fluency in English.

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 Alisa Liddell for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
 

alisa.liddell@adaptivelifescience.com

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