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Associate Regulatory Affairs Specialist

MiniMed -
Maastricht

Nu solliciteren

Vacaturegegevens

Fulltime

Kwalificaties

Frans
Microsoft Excel
Computervaardigheden
Engineering
Engels
Microsoft Office
Administratieve ervaring
Bachelor
Farmacie
Veiligheid
Computervaardigheden
Duits
Tijdmanagement

Volledige vacaturetekst

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

As a Regulatory Affairs & Quality Specialist, you will play a key role in supporting 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 and post-market surveillance activities, and help drive compliance across the business.

You will also be responsible for maintaining local quality procedures and work instructions, while partnering with global Quality teams to ensure local regulatory requirements are effectively incorporated into global processes and documentation. This role offers the opportunity to work in a dynamic international environment, acting as a bridge between local business needs and global regulatory and quality standards.

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 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 the 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 to i.e., Field Action or Vigilance activities. This includes updating the 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 to the Regulations and Minimed procedures
Monitors the shared mailbox by providing support to tender requests, customer requests, 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 share experience and knowledge
Participation 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 related university degree (Regulatory Affairs, Pharmacy, Engineering or other scientific degree)
Clear communication, proficient French and English language. In addition, Dutch and/or German
Quality oriented, Integrity, Continuous Learning, Interpersonal Effectiveness, being proud to deliver quality, time management, Confident 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

#BetterDaysStartNow

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

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.

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