Head of Regulatory Affairs

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
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