QA/RA Manager (m / w / d)
Based in Hamburg
Our client is a privately-owned global leader in Ophthalmic medical devices. Due to product expansion, growth in new markets and the new European regulations, they are looking to strengthen their team with a QA/RA Manager. This position will work closely with the Head of R&D and the CEO, offering a collaborative culture and an innovative working environment.
- Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes
- You review and approve device related development documentation by overseeing the design control process and the whole device related life cycle process
- Participation in and performance of internal and external audits
- Working to ISO 13485
- Manage the verification and validation of the company software products and systems according to internal software lifecycle management processes
- 3-5 years of RA/QM experience at a Medical Device company (Ideally with expertise in Ophthalmic Devices)
- Academic technical background, or from a Quality Engineering position
- Weighted focus on quality management systems to ISO 13485
- Experience in the MDD/MDR transition for Europe
This is a remote opportunity.
Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.