We are seeking an experienced Regulatory Affairs (RA) Consultant to support regulatory activities for a Class IIa medical device.
Responsibilities:
- Oversee post-market regulatory compliance for Class IIa devices.
- Develop, review, and update technical documentation.
- Ensure adherence to IEC 62304 (Medical device software lifecycle) and IEC 60601 (Medical electrical safety standards).
- Provide guidance on compliance with EU MDR and FDA regulations.
- Specific FDA experience relates to 510(k) pre market notifications.
Requirements:
- Proven experience in medical device regulatory affairs.
- Strong knowledge of IEC 62304 and IEC 60601.
- Familiarity with EU MDR and FDA requirements.
- Ability to manage and maintain technical files.
Must reside in the Netherlands.
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