Senior Director of Quality & Regulatory Affairs - Europe

  • East of England/Anglia,North East,North West,Yorkshire and Humber,East Midlands,West Midlands,London,South East Coast,South Central,South West,Scotland,Wales,Republic Of Ireland,Northern Ireland,Western Europe
  • Highly competitive salary & package in line with experience
  • Ref: 7403

About the Job

Title: Senior Director of Quality and Regulatory Affairs
Location: Working across Europe but preferably based in Belgium or Luxembourg
Salary: Highly competitive salary + exceptional benefits on offer
Ref: 7403

A brand-new opportunity with a privately-owned healthcare company, as they continue their growth across Europe with a leading Woundcare portfolio!

Interested? Please get in contact with us on 0113 457 0777 to speak to a member of the team!

Role Responsibilities

  • Defining Quality and Regulatory Strategy and Positioning: drafting, reviewing, and strategizing EU, US and international regulatory submissions and Technical Documentation
  • Reviewing Regulatory Compliance of marketing/labelling materials, post commercialization Compliance
  • Manage a team of approximately 10 regulatory, quality and clinical staff and consultants where needed
  • Developing and maintaining quality vision and strategies to drive excellence throughout the organisation to ensure compliance with the applicable legislation and to ensure reliable delivery of high-quality products meeting or exceeding customer and relevant requirements
  • Managing procedures and inspection/audit programs to ensure meeting relevant requirements
  • Developing and maintaining clinical strategies and clinical data management to build clinical excellence around products for registration and health economic (cost-effectiveness) purposes
  • Actively participating in cross-functional/regional strategic initiatives and teams as appropriate to deliver enterprise quality solutions and to provide Regulatory guidance on development
  • Participation in international executive management meetings
  • Direct report to the Executive Chairman and periodically reporting to group Advisory Board

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