Regulatory Affairs Associate — Benelux (Flex Work)

Medtronic; Eindhoven; Hybrid; EUR 44,000 - 66,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Flexible work arrangement

Job summary

Medtronic Benelux is seeking an Associate Regulatory Affairs Specialist to support post-market surveillance, vigilance, and regulatory compliance across the Benelux region. You will collaborate with quality and regulatory teams to ensure patient safety and adherence to ISO 13485.

The role is based in Maastricht or Heerlen, with a flex work arrangement requiring presence in Eindhoven or Heerlen twice per week and occasional travel within the territory.

Qualifications

• Bachelor's degree with 0+ years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
• Fluency in English and Dutch, both written and spoken.
• Advanced proficiency in Microsoft Office applications and database systems.
• Experience managing multiple priorities with strong organizational and administrative skills.

Responsibilities

• Coordinate the preparation, execution, and follow-up of field safety corrective actions and product hold activities within the Benelux region.
• Manage inquiries from competent authorities related to vigilance activities and field safety corrective actions.
• Advise sales teams on product complaint handling and product return processes in compliance with regulatory requirements and company procedures.
• Support Quality Management System activities, including supplier management, distributor management, document control, and key performance indicator monitoring.
• Monitor regulatory developments and support implementation of new regulatory requirements affecting the Benelux region.
• Manage shared regulatory mailboxes and respond to internal, tender, and customer requests.
• Support promotional and marketing activities by reviewing materials for regulatory compliance.
• Collaborate with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.

Skills

Regulatory Affairs

English

Dutch

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Database systems

Job description

Medtronic Benelux is seeking an Associate Regulatory Affairs Specialist to support post-market surveillance, vigilance, and regulatory compliance across the Benelux region. You will collaborate with quality and regulatory teams to ensure patient safety and adherence to ISO 13485.

The role is based in Maastricht or Heerlen, with a flex work arrangement requiring presence in Eindhoven or Heerlen twice per week and occasional travel within the territory.