Regulatory Affairs Associate - Benelux & Quality

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

Benefits offered by this job

Flexible Benefits Package

Hybrid work arrangement

Job summary

Medtronic is seeking an Associate Regulatory Affairs Specialist to support the Benelux region from Maastricht or Heerlen with a flex/hybrid work setup. You will assist with post-market surveillance, field safety actions, and interactions with authorities while collaborating with sales, quality, and operations teams.

The role requires a Bachelor’s degree and fluency in English and Dutch, plus strong organizational skills and attention to detail in a regulated environment.

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.
• Ability to work accurately with high attention to detail in a regulated environment.

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 KPI 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

English and Dutch fluency

MS Office proficiency

Organizational skills

Attention to detail

Education

Bachelor's degree

Tools

Database systems

Job description

Medtronic is seeking an Associate Regulatory Affairs Specialist to support the Benelux region from Maastricht or Heerlen with a flex/hybrid work setup. You will assist with post-market surveillance, field safety actions, and interactions with authorities while collaborating with sales, quality, and operations teams.

The role requires a Bachelor’s degree and fluency in English and Dutch, plus strong organizational skills and attention to detail in a regulated environment.