Senior Quality Assurance Specialist

vor 3 Wochen


Munich, Bayern, Deutschland BioTalent Vollzeit

As the Senior Quality and Regulatory Affairs Manager at BioTalent, you will play a critical role in ensuring the company's products meet the highest standards of quality and regulatory compliance.

Our client specializes in oncology and is focused on developing breakthrough non-invasive therapies. They currently market their products in Europe, Australia, and Africa, and are in the process of securing US entry.

  • Responsibilities
  • Establish and maintain QMS requirements.
  • Mentor junior QA peers and assist with regulatory authority interactions.
  • Participate in internal and external audits, and regulatory inspections.
  • Review and manage SOPs and other Quality Management documents.
  • Manage technical documentation for submissions and product changes.
  • Involvement in process optimization for QARA processes.
  • Ensure global QARA compliance.

Requirements

  • Engineering or science-related educational background.
  • Minimum 4 years of experience in Quality and Regulatory Affairs for medical devices.
  • Prior FDA interaction, preferably with submission and technical documentation for 510k/De Novo processes.
  • Knowledge of ISO 13485, MDR, and ISO 9001.
  • Experience with risk management.
  • Fluency in English required, B2 level of German desirable.


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