Regulatory Affairs Specialist

Regulatory Affairs & Quality Specialist

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, post‑market surveillance, and help drive compliance across the business. You will also maintain local quality procedures and work instructions, partnering with global Quality teams to incorporate local regulatory requirements into global processes and documentation. The role is a hybrid position requiring a minimum of two days per week at one of our offices located in Paris, Maastricht, Heerlen, or Eindhoven.

Responsibilities

• 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 records evidence, allowing timely closure of the Benelux & France FSCA's.
• Reconciliation activities in collaboration with the FSCA Support Team.
• Follow‑up on inquiries from the Competent Authority regarding Field Action or Vigilance activities, including updating Minimed reporting systems and record keeping.
• Support on Post‑Market Surveillance – provide advice to sales team members on product complaint handling processes and returns, to assure compliance with regulations and Minimed procedures.
• Monitor the shared mailbox by providing support to tender requests, customer requests, and internal stakeholder requests.
• Sourcing, verifying and providing regulatory documents to customers and other stakeholders.
• Connecting requests to the appropriate teams, ensuring adequate and complete follow‑up.
• Close collaboration with peers in EMEA by supporting each other and sharing experience and knowledge.
• Participation in quality and regulatory improvement initiatives to simplify and optimize processes.

Qualifications

• 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, proficient French and English language; Dutch and/or German desirable.
• Quality oriented, integrity, continuous learning, interpersonal effectiveness, pride in delivering quality, time management and confidence to share smarter ways of working or innovative ideas.
• Advanced computer skills – Microsoft Office including advanced Excel skills and ability to use custom organizational software.
• Autonomy and pro‑activity, continuous learning, attention to detail, organizational and strong administrative skills.

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

MiniMed offers a competitive salary and flexible benefits package.

EEO Statement

It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees.