Senior Consultant Medical Devices Quality & Regulatory Affairs
Qserve GroupGermany
Posted December 14, 2024
Full Time
About the Company
Qserve Group is a global partner for regulatory, clinical, and quality compliance services for medical devices and in vitro diagnostics, as well as a CRO for medical device clinical trials.
Job Description
Join Qserve as a Senior Consultant Medical Devices Quality & Regulatory Affairs and support clients in the medical device industry with regulatory compliance and market access. Work collaboratively with a global team to deliver high-quality support.
Requirements
- Technical or scientific degree (BSc, MSc, or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology, or a related field.
- At least 7 years of professional experience in the medical device field (EU MDD and EU MDR), gained in industry, consultancy, or a Notified Body, in quality, regulatory, or clinical roles.
- Solid knowledge of quality assurance and regulatory affairs within the MedTech industry or a Notified Body environment.
- Qualified to perform ISO 13485 and MDSAP audits as a lead auditor.
- In-depth knowledge of EU Medical Device Regulations (EU MDR) and US regulations.
- Familiarity with medical device risk management.
- Hands-on experience in writing technical and regulatory documentation.
- Experience in implementing and managing medical device quality management systems (ISO 13485).
- Practical knowledge of project management.
- Fluent in English and German.