QARA Manager, Benelux & Nordics — Regulatory Lead

Antler Co; Amersfoort; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

None

Job summary

Johnson & Johnson's DePuy Synthes division seeks a Manager of QA & Regulatory Affairs for Benelux & Nordics, located in Amersfoort, Netherlands. You will lead QA and regulatory activities across Benelux and Nordic markets, ensuring compliance and enabling market access for the Orthopedics portfolio in a regulated European setting.

The role partners with local teams and global QARA, managing submissions and lifecycle activities while maintaining patient safety and supply continuity in

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
• Strong knowledge of EU MDR and multi-country regulatory environments.

Responsibilities

• Lead QA and Regulatory Affairs activities to support registrations, renewals and lifecycle management across Benelux and Nordic markets.
• Ensure compliance with EU MDR, country requirements, standards and quality policies.
• Coordinate regulatory submissions, technical documentation and health authority responses.
• Serve as primary QARA contact for Benelux & Nordics Local Market Support.
• Collaborate with Quality, Supply Chain, Legal and Global QARA to support objectives.

Skills

Regulatory Affairs

Quality Assurance

Stakeholder management

Regulatory compliance

Communication

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline

Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field

Job description

Johnson & Johnson's DePuy Synthes division seeks a Manager of QA & Regulatory Affairs for Benelux & Nordics, located in Amersfoort, Netherlands. You will lead QA and regulatory activities across Benelux and Nordic markets, ensuring compliance and enabling market access for the Orthopedics portfolio in a regulated European setting.

The role partners with local teams and global QARA, managing submissions and lifecycle activities while maintaining patient safety and supply continuity in