Manager, QARA Benelux & Nordics (MedTech)

Location: Hybrid role based in Amersfoort, Utrecht, Netherlands; Belgian citizenship and a valid Belgian passport are required. Occasional regional travel within Benelux and the Nordics is expected.

Base pay: €68,600–€119,600 annually, plus an annual bonus or sales commissions depending on role and location.

Company

Johnson & Johnson MedTech develops healthcare and orthopedic solutions, with this position supporting the DePuy Synthes portfolio.

What you will do

• Lead Quality Assurance and Regulatory Affairs activities across Benelux and Nordic markets.
• Manage product registrations, renewals, variations, and lifecycle activities.
• Ensure compliance with EU MDR, country-specific requirements, applicable standards, and quality management system policies.
• Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries.
• Partner with Quality, Supply Chain, Commercial, Legal, and global QARA stakeholders to support product decisions and supply continuity.
• Monitor regulatory changes, assess risks, support inspections and audits, and improve inspection readiness.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• 6–8 years of progressive Quality Assurance and/or Regulatory Affairs experience in medical devices, healthcare, or another regulated industry.
• Strong knowledge of EU MDR and Benelux/Nordic regulatory environments.
• Experience managing registrations and product lifecycle activities across multiple European markets.
• Strong stakeholder management, communication, collaboration, and prioritization skills in complex matrixed environments.
• Belgian citizenship and a valid Belgian passport are mandatory. English is required; Dutch and/or French are preferred.

Nice to have

• Advanced degree or certification in Regulatory Affairs or Quality, such as RAC.
• Experience with multi-country QARA portfolios, inspections, audits, post-market surveillance, or vigilance.
• Experience in multinational or matrixed organizations and regulatory or quality process improvement.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and equal opportunity.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, recognition awards, and performance-based annual bonus opportunities.