Quality Assurance and Regulatory Affairs Manager

hace 2 semanas


Barcelona, Barcelona, España Mcr International A tiempo completo
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 Department, you will be responsible for ensuring full company compliance with MDR, ISO 13485, and 9001 requirements, as well as internal quality manuals, procedures, and instructions.

Key Responsibilities:
  • 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 budget of the Quality department
  • 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
  • Education and experience: 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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