Senior Regulatory Affairs Officer (US Region)

Senior Regulatory Affairs Officer
 
Location: On-site in Geneva, Switzerland 

Join a dynamic team specializing in the design and manufacturing of hyaluronic acid-based dermal fillers. As a Senior Regulatory Affairs Officer, you will be integral to shaping regulatory strategies for our innovative product range, managing regulatory submissions, and ensuring compliance with FDA requirements. You will coordinate responses to FDA inquiries, review product labeling, and participate in audits and inspections. 

Key Responsibilities:

• Develop and implement regulatory strategies within cross-functional teams.
• Manage regulatory submissions (e.g., IDEs, PMAs) and ensure compliance with FDA requirements.
• Coordinate responses to FDA inquiries and review product labeling.
• Participate in audits and inspections to ensure regulatory compliance.
• Maintain and update regulatory databases and SOPs.

Requirements:

• +6  years of experience in the medical device industry.
• Proficient in quality standards (ISO 13485) and regulations (21 CFR Part 820, MDR 2017/745).
• Strong analytical and critical thinking skills.
• Ability to manage multiple projects and prioritize effectively.
• Fluent in English and good level of French.

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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