Regulatory Affairs Specialist

About the Role

As a Regulatory Affairs & Quality Specialist, you will support regulatory and quality activities across Benelux and France, ensuring compliance with EU and local regulations throughout the product lifecycle. You will work closely with competent authorities, customers, tender organizations, and internal stakeholders to provide regulatory guidance, support field actions and post‑market surveillance activities, and help drive compliance across the business. Your responsibilities also include maintaining local quality procedures and work instructions and partnering with global quality teams to integrate local regulatory requirements into global processes and documentation.

Responsibilities

• Preparation, execution, and follow‑up of FSCA’s (Field Safety Corrective Actions) according to the enterprise plan; collaborating with sales managers and representatives to collect evidence for timely closure of Benelux & France FSCA’s.
• Follow‑up on inquiries from the Competent Authority regarding Field Action or Vigilance activities, updating reporting systems and maintaining records.
• Support post‑market surveillance, advising sales teams on product complaint handling and returns to ensure regulatory compliance.
• Monitor the shared mailbox to support tender requests, customer requests, and internal stakeholder inquiries.
• Source, verify, and provide regulatory documents to customers and stakeholders.
• Connect requests to appropriate teams, ensuring adequate and complete follow‑up.
• Collaborate with peers in EMEA to share experience and knowledge.
• Participate in quality and regulatory improvement initiatives to simplify and optimise processes.

Required Knowledge, Experience and Skills

• 3–5 years of medical device regulatory, quality, or product‑related experience, or a related university degree (Regulatory Affairs, Pharmacy, Engineering, or other scientific degree).
• Clear communication with proficiency in French and English; additional Dutch and/or German preferred.
• Quality orientation, integrity, continuous learning, interpersonal effectiveness, and a focus on delivering quality.
• Advanced computer skills (Microsoft Office, including advanced Excel, and ability to use custom organisational software).
• Autonomy, pro‑activity, continuous learning, and strong attention to detail.
• Organisational and strong administrative skills.

Physical Job Requirements

The above statements describe the general nature and level of work performed in this position. They are not an exhaustive list of all responsibilities and skills required.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. We put people first, recognizing their contributions and offering a wide range of benefits, resources, and competitive compensation plans to support each stage of a career and life.

About MiniMed

We strive to make every day better for people living with diabetes. Our global team of innovators works on simple solutions and predictive insights, dedicating ourselves to support customers throughout their journey and meet them where they need us.