Quality Assurance and Regulatory Affairs Manager

hace 2 días

Madrid, Madrid, España Mcr International A tiempo completo
Job Title: Quality Assurance and Regulatory Affairs Manager

Mcr International is seeking a highly skilled Quality Assurance and Regulatory Affairs Manager to join our team in Madrid. As a key member of our Quality Assurance department, you will be responsible for ensuring the company's compliance with MDR, ISO 13485, and 9001 requirements.

Key Responsibilities:

  • Participate in the implementation of a total quality culture in the company, ensuring full compliance with regulatory requirements.
  • Maintenance and improvement of QMS, including SOP and WI development.
  • Lead general regulatory audits and approval submissions.
  • Drive internal and supplier audits.
  • Coordinate and manage Management Meeting Review, including the maintenance of QA metrics (KPIs).
  • Management and monitoring of non-conformities and CAPAs.
  • Management of QMS SW validations.
  • Management, design, and performance of QA training.
  • Support in the management of the Quality department's budget.
  • Support the Engineering and Manufacturing department in Quality and Regulatory Aspects of operations management – Management of DCOs (Document Change Orders).
  • Management of suppliers' evaluation.

Regulatory Assurance – Requirements:

  • Maintenance of Regulatory Environment.
  • Participate in the preliminary work for FDA, CE, and other medical approval processes in collaboration with agents, approval bodies, and consultants/CROs.
  • Participate in the documentation for regulatory approval bodies and consultants.
  • Coordinate Risk Assessment and Analysis throughout QMS and Product Development/Manufacturing.
  • Support V&V activities.
  • Support Clinical Investigations Submission to NCA and ECs.

Requirements:

  • Experience in the HealthCare Sector (>3/5 years).
  • Trainee experience in Quality Assurance, Quality Control.
  • Thorough knowledge of ISO 13485:2016, ISO 9001:2015, and relevant Medical ISO standards, MDR, along US-FDA Regulations.
  • Knowledge in GMP, GLP, GDP.
  • Industrial Engineering, Science, or Medical Device Technology Degree.
  • English (ALTE-4 or higher).
  • Prior experience in the medical device industry.
  • Certified Quality Auditor (preferably).

Reporting Line: Head of QA and VP Regulatory and Clinical Affairs

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