EPM Scientific are looking for a team of experienced consultants, to join our Medical Device client based near Copenhagen, Denmark.
The initial project is focussed around a 510k submission, once completed focus will shift towards improving and maintaing compliance to ISO 13485.
We are looking for consultants across the following verticals:
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Validation
- Software
- Cyber Security
- Training & Education
Skills & Experience:
- 10+ years in the Medical Device Industry
- Strong understanding of ISO 13485
- Experience working with SaMD
- FDA 510k experience (preffered)
- IEC 62304 & EN 60601 (preffered)
Contract Info:
- Start: January 2025
- Duration: 12 months
- Hours: Full time, 40 hours
- Location: Denmark (Hybrid)
