Assoc. Regelgevende zaken spec.

Bij Medtronic kunt u een levenslange carrière van ontdekking en innovatie beginnen en tegelijk toegang tot gezondheidszorg en een gelijke behandeling voor iedereen bevorderen. U zult doelgericht leidinggeven en barrières slechten voor innovatie in een wereld met meer verbondenheid en compassie.

Als Associate Regulatory Affairs Specialist ondersteunt u Quality and Regulatory Compliance activities across the Benelux region. Voltijd.

• Assoc. Regelgevende zaken spec.
• Flexibele werkregeling
• Eindhoven, Noord-Brabant, Netherlands
• Heerlen, Limburg, Netherlands

Een dag uit het leven

The Regulatory Affairs function within Medtronic Benelux supports compliance with medical device regulations and quality requirements across Belgium, the Netherlands, and Luxembourg. Working closely with commercial, quality, and regulatory teams, the function helps ensure patient safety, effective post-market surveillance, regulatory compliance, and timely engagement with competent authorities and customers.

This position is based in Maastricht or Heerlen, Netherlands, and follows a Flex work arrangement, you are expected to work from the Eindhoven or Heerlen office twice per week. The role supports stakeholders across the Benelux region and may require limited travel within the territory as business needs arise.

You will work with experienced Regulatory Affairs professionals to support post-market surveillance activities, field safety corrective actions, interactions with competent authorities, and quality management system processes. The role requires strong organizational skills, attention to detail, and effective collaboration with commercial and operational teams.

Primary 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.

Required 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.

Preferred Qualifications

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

Secundaire arbeidsvoorwaarden en compensatie

Medtronic biedt een competitief salaris en een flexibel pakket secundaire arbeidsvoorwaarden

Betrokkenheid bij onze werknemers behoort tot onze kernwaarden. We waarderen hun bijdragen. Ze delen in het succes waar ze aan bijdragen. We bieden een breed scala aan secundaire arbeidsvoorwaarden, middelen en aantrekkelijke compensatieregelingen die zijn ontworpen om u in elke carrière- en levensfase te ondersteunen.

Pay range / Rango salarial / Intervalo salarial / Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 43,840.00 EUR - 65,760.00 EUR

The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).