Regulatory Affairs Associate – Benelux (Flexible)

NLS Medtronic Trading NL B.V.; Eindhoven; Hybrid; EUR 44,000 - 66,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Job summary

Medtronic Benelux seeks an Associate Regulatory Affairs Specialist to support post‑market surveillance and quality management across Belgium, the Netherlands, and Luxembourg. The role collaborates with regulatory, quality and commercial teams to ensure patient safety and regulatory compliance.

Based in Maastricht or Heerlen with a flex work arrangement, you will engage with authorities and customers, handle inquiries, and help implement new regulatory requirements across the Benelux region.

Qualifications

• Bachelor's degree in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare or related field.
• Fluent in English and Dutch (written and spoken).
• Excellent MS Office and database skills.

Responsibilities

• Coordinate post‑market surveillance activities and field safety actions within the Benelux region.
• Liaise with competent authorities on vigilance and regulatory questions.
• Advise sales on product complaint handling and returns per regulatory requirements.
• Support Quality Management System activities, including supplier and distributor management and document control.
• Monitor regulatory developments and support implementation of new requirements.
• Manage shared regulatory mailboxes and respond to internal, tender and customer requests.
• Review promotional materials for regulatory compliance and collaborate with regional teams.

Skills

Regulatory Affairs

Quality Assurance

Organizational skills

Multitasking

Education

Bachelor's degree in Regulatory Affairs or Life Sciences

Tools

MS Office

Database systems

Job description

Medtronic Benelux seeks an Associate Regulatory Affairs Specialist to support post‑market surveillance and quality management across Belgium, the Netherlands, and Luxembourg. The role collaborates with regulatory, quality and commercial teams to ensure patient safety and regulatory compliance.

Based in Maastricht or Heerlen with a flex work arrangement, you will engage with authorities and customers, handle inquiries, and help implement new regulatory requirements across the Benelux region.