Senior Manager – 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 james.allen@darwinrecruitment.com for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.