Senior Quality and Regulatory Affairs Manager

Vor 4 Tagen


Munich, Bayern, Deutschland BioTalent Vollzeit
Join Our Team as a Senior Quality and Regulatory Affairs Manager

BioTalent is partnering with a leading Medical Device organization to fill a critical role in their commercialization journey. As a Senior Quality and Regulatory Affairs Manager, you will be responsible for reviewing and managing SOPs and other Quality Management documents. Your expertise will also be utilized in the management of technical documentation for submissions and product changes, ensuring global QARA compliance.

Key Responsibilities:

  • Review and manage SOPs and other Quality Management documents
  • Manage technical documentation for submissions and product changes
  • Ensure global QARA compliance

Requirements:

  • Minimum of 4 years' experience in Quality and Regulatory affairs for medical devices
  • Experience with risk management
  • Fluency in English required, B2 level of German is desirable

BioTalent is committed to finding the best talent for this role. If you are a motivated and experienced Quality and Regulatory Affairs professional, we encourage you to apply. Please note that we are looking for a candidate who can work in a fast-paced environment and is passionate about ensuring the highest quality standards in medical devices.



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