Quality – Regulatory Affairs Manager

Building on the success of its medical device distribution service in the United States and as part of its growth strategy in Europe, Medline Services is expanding its 'Prime Vendor' solution to hospitals and clinics in Europe.

In order to guarantee high quality standards to our customers, we are looking for Quality – Regulatory Affairs Manager.

Your Duties

  • Lead all Quality and Regulatory activities in Europe for Prime Vendor. Work with counterparts within the QRA Organization to set-up and maintain all appropriate processes, address all topics and challenges both internally and externally.
  • QMS documentation administration for all EU Prime Vendor QM Systems, performing document reviews and maintenance of documents. QMS Training Administration.
  • Conduct internal and external audits
  • Lead QRA relationship with Prime Vendor 3PL partners
  • QARA master data management for all Prime Vendor items in Europe (Warehouse and Data Coordination)
  • Accountable for all Prime Vendor product complaints in Europe. Manage directly all products complaints and potential recall/field safety notices.
  • Support Customer Services and Operations with respect to addressing/resolving service complaints.
  • Provide regulatory guidance to the Prime Vendor business. Make sure all appropriate rules and regulations are applied.
  • Lead appropriate certifications for all PV sites including Pharma if applicable. Implement the new MDR for PV business.

Your Profile

  • Five years minimum of experience in regulatory affairs or in quality management systems relating to medical devices and/or pharmaceutical products (GDP)
  • Scientific education or Bachelor degree in quality management, Pharmacist a plus
  • Professional experience in the field of quality management in an international environment
  • Knowledge and understanding of EC requirements for Medicinal Products, and GDP incl. quality management system.
  • Completed training as an internal auditor as a plus
  • Positive attitude, results oriented
  • Leadership experience
  • Eager to learn, team player and persuasive. Strong communication and organizational skills
  • Excellent skills in IT system including Microsoft Office Programs, ERP, BI system and WMS as a plus
  • Fluent English and French (written and oral communication), German as a plus
  • Willingness to travel in Europe

Location: Châteaubriant (France), Voisins Le Bretonneux (France) ou Kleve (Germany)

Contact

For further information, please send your CV to [email protected]

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