Associate Regulatory Affairs Specialist

Medtronic

. Coordinate the preparation, execution, and follow-up of field safety corrective actions and product hold activities within the Benelux region .

Posted 10/8/2026full-timeEindhoven • NetherlandsJuniorMid-Level💰 €43,840 - €65,760 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and Quality Management within the healthcare or medical device industry, with a strong focus on compliance, product safety, and effective communication in a multicultural environment.

Highest-signal resume keywords

Regulatory AffairsQuality Management SystemMedical Device RegulationsVigilance ProcessesISO 13485

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceProduct Complaint HandlingDocument ControlKey Performance Indicator MonitoringPost-Market SurveillanceDatabase SystemsMicrosoft Office Applications

Soft Skills

Organizational SkillsAttention to DetailProactive Working Style

Industry Keywords

HealthcareLife SciencesBiomedical SciencesMulticultural EnvironmentField Safety Corrective Actions

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
Knowledge of French or German preferred
Knowledge of medical device regulations, post-market surveillance, or vigilance processes preferred
Experience working within a Quality Management System certified to ISO 13485 preferred
Experience supporting regulatory, quality, or compliance activities in the healthcare or medical device industry preferred
Proactive working style and ability to work effectively in a multicultural environment preferred

Benefits

Comp & perks

Flexible Work Arrangement
Competitive Salary and flexible Benefits Package
Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage
Eligibility for the Medtronic Incentive Plan (MIP) short-term incentive