Director, Major Markets Europe & Canada

Johnson & Johnson Johnson & Johnson · Pharma · Vienna, Austria +1

Director of Regulatory Affairs for Major Markets Europe & Canada at Johnson & Johnson (DePuy Synthes). Responsible for leading regulatory strategy, ensuring compliance with EU, Canadian, and country-specific requirements, and enabling market access for medical devices. Partners with cross-functional teams, manages regulatory risk, and leads regional regulatory teams.

What you'd actually do

  1. Lead and oversee regulatory affairs strategy and execution for Major Markets Europe and Canada, aligned with global regulatory objectives.
  2. Ensure compliance with EU, Canadian, and country-specific regulatory requirements, internal policies, and quality system standards.
  3. Provide strategic regulatory guidance for product registrations, renewals, variations, and lifecycle management.
  4. Serve as the senior regulatory leader and escalation point for Europe and Canada local market support.
  5. Partner with cross-functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.

Skills

Required

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline
  • 10-12 years of progressive experience in Regulatory Affairs within the medical device or other regulated industries
  • Strong knowledge of EU MDR, UK, and Canadian regulatory requirements and health authority processes
  • Demonstrated experience leading multi-country regulatory portfolios in major markets
  • Proven ability to develop and execute regulatory strategies aligned to business objectives
  • Strong leadership, stakeholder management, and decision-making capabilities
  • Ability to manage regulatory complexity and risk in a dynamic, global environment

Nice to have

  • Advanced degree or professional certification in Regulatory Affairs
  • Experience supporting global regulatory operating models
  • Experience working in a global, matrixed organization
  • Exposure to regulatory inspections, audits, and authority negotiations
  • Demonstrated success driving regulatory transformation or process improvement initiatives
  • Background in medical devices, healthcare, or other highly regulated industries
  • Additional European languages preferred
  • RAC or equivalent preferred

What the JD emphasized

  • EU MDR
  • Canadian regulatory requirements
  • country-specific regulatory requirements