Head of Regulatory Affairs (Europe & USA)
About the Role
Head of Regulatory Affairs
Location: On-site in Geneva, Switzerland
Our client, a leading innovator in the design and manufacturing of combination medical device products is seeking a Head of Regulatory Affairs. This role involves overseeing the EMEA and US regulatory teams dedicated to Innovation and Life-Cycle projects.
Main Responsibilities:
- Develop and implement regulatory strategies aligned with business objectives.
- 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.
- Manage regulatory responses and ensure effective team communication.
- Support QMS optimization and continuous improvement.
Requirements and Skills:
- Minimum 10 years of experience in regulatory affairs within Medical Technology
- Extensive knowledge of EU regulations and experience negotiating with regulatory agencies and Notified Bodies.
- Proven leadership abilities, including team management experience, mentorship, and strong decision-making skills.
- Strategic thinking and the ability to thrive in a dynamic environment.
- Diploma and experience to act as Deputy PRRC.
- Fluency in English
- Good level of French language preferred.
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
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