Senior Manager – Regulatory Affairs
Senior Manager – Regulatory Affairs
Nyon
Switzerland
Permanent
Medical & Regulatory Affairs
Regulatory Affairs Manager – Switzerland – Medical Devices
Title: Regulatory Affairs Manager
Reporting To: Director – Regulatory Affairs
Industry: Life Sciences – Medical Devices
Salary: Negotiable – depends on experience
Location: Switzerland
At Darwin Recruitment, we are proud to be partnered with a leading medical device company who are helping people recover from debilitating injuries and illnesses. Their medical devices are approved for global use, and they continue to push the boundaries to help more people each year.
Position Overview:
You will be working for this company as a Regulatory Affairs Manager. This role offers an exciting opportunity to lead a Regulatory Affairs team, guiding the regulatory strategy throughout the product lifecycle-from design and development to evaluation, labelling, and marketing. The primary responsibility is to ensure that products comply with applicable regulatory standards and requirements.
Your Responsibilities:
Your responsibilities include but not limited to the following:
- Preparation of fillings for global regulatory boards
- Collaborate with cross-functional teams, offering your expert regulatory knowledge when it comes to design, development and marketing
- Understand the complexity of regulations within ISO, EU MDR and FDA approvals
- Be a mentor and leader for junior members of the team
Your Qualifications:
- Bachelors of Masters degree in Engineering (or a related topic)
- Over 10 years experience in medical devices
- Strong knowledge and experience of ISO regulations, EU MDR and FDA Approvals
- Fluency in English and French
Please apply or email Write an email for more information.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
James Allen
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