QA/RA Manager

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.

Your Responsibilities:

  • 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

Experience Required:

  • 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.

Rebecca.Stevens@Adaptivelifescience.com