Regulatory Affairs and Quality Specialist

Vor 3 Tagen


Berlin, Deutschland BioTalent Vollzeit

**Senior Quality Assurance & Regulatory Specialist**:
**Introduction**:
A spin-off of one of the world’s largest In-Vitro Diagnostics (IVD) manufacturers, located in Berlin is currently searching for an experienced Quality Assurance & Regulatory Affairs Specialist to join their ever growing team after a successful merger.

**This role will offer you**:

- The opportunity to join a start-up environment, now heavily invested in by it’s parent company
- Opportunity for growth in your career with role progression and education
- Opportunity to work in a flat hierarchy

**You will be responsible for**:

- IVD Submissions According to EU Regulations (EU-IVDR)
- Ensuring Regulatory Compliance to Appropriate Standards
- Post-Market Surveillance Activities
- Vigilance Reporting
- Quality Management Systems Implementation (ISO13485)

**You will bring the following**:

- 2+ Years’ Experience in Quality Assurance in the IVD Space (ISO13485)
- EU-Regulatory Submissions
- Experience as Point of Contact for Notified Body
- Education in Scientific / Engineering Studies

BioTalent Ltd are acting as an employment agency in relation to this opportunity.



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