Regulatory Affairs Consultant

We are seeking an experienced Regulatory Affairs Consultant to support our medical device regulatory team. This is a remote freelance position with an immediate start.

Key Responsibilities:

• Prepare and manage regulatory submissions in compliance with EU MDR.
• Provide strategic regulatory input for medical device projects.
• Collaborate with cross-functional teams to ensure documentation aligns with regulatory standards.
• Support CE marking processes and ongoing compliance efforts.
• Draft high-quality regulatory documents in English and French.

Requirements:

• Minimum 5 years of experience in Regulatory Affairs within the medical device industry.
• In-depth knowledge of MDR (EU 2017/745) requirements.
• Fluent in English and French, both written and spoken.
• Strong technical writing skills for regulatory submissions and documentation.
• Ability to work independently and meet tight deadlines.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

Greg King