Associate 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.

Working closely with Competent Authorities, customers, tender organizations, and internal stakeholders, you will provide regulatory guidance, support field actions, post‑market surveillance activities, and help drive compliance across the business.

You will maintain local quality procedures and work instructions, partnering with global Quality teams to ensure local regulatory requirements are incorporated into global processes and documentation.

This is a hybrid position requiring a minimum of two days per week in one of our offices located in Paris, Maastricht, Heerlen, or Eindhoven.

Responsibilities

• Prepare, execute, and follow up on FSCA (Field Safety Corrective Actions) according to the enterprise plan, collaborating with sales managers and representatives to collect evidence and ensure timely closure of the Benelux & France FSCA's.
• Follow up on inquiries from Competent Authorities related to field actions or vigilance activities, updating the Minimed reporting systems and maintaining records.
• Support post‑market surveillance by advising sales team members on product complaint handling processes and returns, ensuring compliance with regulations and Minimed procedures.
• Monitor the shared mailbox, providing support for tender requests, customer requests, and internal stakeholder queries.
• Sourcing, verifying, and providing regulatory documents to customers and other stakeholders.
• Connecting requests to the appropriate teams and ensuring thorough follow‑up.
• Collaborate closely with peers in EMEA to share knowledge and support each other.
• Participate in quality and regulatory improvement initiatives to simplify and optimize 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 another scientific degree).
• Clear communication skills; proficiency in French and English. Knowledge of Dutch and/or German is a plus.
• Quality‑oriented mindset, integrity, continuous learning, interpersonal effectiveness, and a proactive approach to delivering quality.
• Advanced computer skills, including Microsoft Office and advanced Excel, and the ability to use custom organizational software.
• Organizational and strong administrative skills, with attention to detail.

Benefits & Compensation

MiniMed offers a competitive salary and a flexible benefits package.