Associate Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this role, you will focus on supporting regulatory affairs field actions and addressing inquiries from the Competent Authority, customers, tenders, marketing, and sales teams. You will also provide guidance and advice to the sales team to ensure compliance with EU and local legislation in the Benelux, specifically related to Post-Market Surveillance activities.

You will report to the Regulatory Affairs Manager. The position requires a minimum of two days per week working from the office in Eindhoven, Maastricht, or Heerlen.

Responsibilities may include the following and other duties may be assigned:

• Preparation, execution, and follow-up of FSCA's (Field Safety Corrective Actions) according to the enterprise plan
• Close collaboration with sales managers and sales representatives to collect/record evidence, enabling timely closure of the Benelux FSCA's
• Reconciliation activities in collaboration with the FSCA Support Team
• Follow-up on inquiries from the Competent Authority related to Field Action or Vigilance activities, including updating Medtronic reporting systems and maintaining accurate record-keeping
• Support on Post-Market Surveillance by advising sales team members on product complaint handling processes and returns to ensure compliance with Regulations and Medtronic procedures
• Monitoring the shared mailbox to provide support for tender requests, customer inquiries, and internal stakeholder requests
• Sourcing, verifying, and providing regulatory documents to customers and other stakeholders
• Connecting requests to the appropriate Operating Unit and ensuring complete follow-up
• Participation in team and process improvement initiatives

Required Knowledge and Experience:

• 3–5 years of experience in medical device regulatory, quality, or product-related roles, or a relevant university degree in Regulatory Affairs, Pharmacy, Engineering, or another scientific discipline
• Proficient in Microsoft Office (with advanced Excel skills) and capable of effectively using custom organizational software
• Autonomous, proactive, detail-oriented, and committed to continuous learning and self-improvement
• Strong administrative and organizational abilities, clear and effective communication in English and Dutch; French and/or German are considered a plus
• Quality-driven, high integrity, innovative mindset, excellent time management, interpersonal effectiveness, and a passion for delivering excellence while confidently proposing smarter ways of working

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package.

About Medtronic

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.