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Medtronic
Medtronic
H1B Visa SponsorHealthcareHealthcare InsuranceManufacturing
Medtronic is a global healthcare technology and manufacturing company developing solutions for complex medical conditions. Its work brings together large, international teams and close collaboration with healthcare professionals to improve treatments, therapies, and access to medical technology. With more than 95,000 employees across over 150 countries, Medtronic focuses on advancing patient care while supporting inclusion, diversity, equity, and sustainable practices across its operations.
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Associate Regulatory Affairs Specialist - Eindhoven, Netherlands (Hybrid)

Support Medtronic’s Benelux medical-device compliance program through vigilance, safety actions, quality systems, and regulatory coordination. Partner with regional teams and authorities to maintain compliant post-market and regulatory processes.

NLNetherlands
€43,840 – €65,760 / year
HybridFull-timeJuniorMiddleEnglish RequiredDutch RequiredCompliance

Description

  • Coordinate field safety corrective actions and product holds across the Benelux region, from preparation through follow-up.
  • Handle competent-authority inquiries concerning vigilance activities and field safety corrective actions.
  • Guide sales teams on compliant product complaint handling and product return procedures.
  • Contribute to Quality Management System activities covering suppliers, distributors, document control, and KPI monitoring.
  • Track regulatory changes and help implement new requirements affecting the Benelux region.
  • Manage shared regulatory inboxes and answer internal, tender, and customer requests.
  • Review promotional and marketing materials for regulatory compliance.
  • Work with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.
  • Support post-market surveillance, safety actions, authority interactions, and Quality Management System processes across the Benelux region.
  • Coordinate with commercial, quality, regulatory, and operational stakeholders.

Requirements

  • Bachelor’s degree with at least 0 years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
  • Fluent written and spoken English and Dutch.
  • Advanced proficiency with Microsoft Office applications and database systems.
  • Demonstrated ability to manage competing priorities with strong organizational and administrative skills.
  • High accuracy and attention to detail when working in a regulated environment.
  • French or German language knowledge is preferred.
  • Knowledge of medical-device regulations, post-market surveillance, or vigilance processes is preferred.
  • Experience with an ISO 13485-certified Quality Management System is preferred.
  • Experience supporting regulatory, quality, or compliance work in healthcare or medical devices is preferred.
  • A proactive approach and effectiveness in multicultural working environments are preferred.

Benefits

  • Flexible work arrangement.
  • Competitive salary with a flexible benefits package.
  • Broad benefits, resources, and competitive compensation plans supporting employees across career and life stages.
  • Short-term incentive through the Medtronic Incentive Plan (MIP).

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