Regulatory & Quality Officer
- Permanent
- Medical devices
Are you a driven professional with a passion for Regulatory Affairs, quality systems, and local compliance in the pharmaceutical industry? Do you want to be part of a dynamic environment where your accuracy, analytical skills, and communication expertise make a difference? Then we’re looking for you as our new Regulatory & Quality Officer!
Vacancy information
About the Role
As a Regulatory & Quality Officer, you’ll be responsible for ensuring compliance with local regulatory and quality standards for our pharmaceutical products, medical devices, and biocides in Belgium and the Netherlands. Acting as the primary point of contact for both local and international teams, you’ll take the initiative to keep processes efficient and compliant.
Key Responsibilities
1. Regulatory Affairs (RA)
Pharma: You’ll coordinate local adjustments and submissions for Belgium and the Netherlands, working closely with Global Regulatory Affairs. Daily operational tasks are handled by an external partner, whom you’ll supervise together with the RA Manager.
Medical Devices: You’ll be responsible for accurate registration and maintenance of our portfolio.
Biocides: You’ll ensure that all licenses remain up to date and closely monitor relevant legislation.
2. Pricing & Reimbursement
You’ll prepare and submit pricing files for pharmaceuticals and medical devices in Belgium. A foundation in Health Economics is essential to support well-founded and successful pricing requests.
3. Local Safety Officer
Oversee vigilance activities for pharmaceuticals, medical devices, and veterinary products, including product complaints, recalls, FSCA, and FSN. If desired, you may lead the vigilance team.
4. Co-RIP and B2B Support
Act as co-Responsible Person (co-RIP) alongside your GDP-RP colleague. You’ll support the B2B team in Belgium and the Netherlands, requiring a solid understanding of GDP, export permits, customs documentation, and change control.
5. Quality Systems
Contribute to the quality system by supporting improvement initiatives (CAPA, change management, procedures, and training) and ensuring compliance with internal and external quality standards.
Requirements information
Your Profile
Experience: At least 3 years of experience in Regulatory Affairs, quality management, or a similar role within the pharmaceutical or medical device industry.
Attributes: Precise, analytical, and knowledgeable. You have a “can-do” mentality, take initiative, and are an effective communicator and mediator between local and global teams.
Skills: Strong project management skills with excellent reporting and team leadership abilities. You’re solution-oriented and capable of handling responsibility.
Knowledge: A foundation in GDP, Health Economics, and quality systems is essential.
Languages: You are fluent in Dutch, French, and English.
What We Offer
- A challenging role in an international and dynamic environment with room for personal initiative.
- Opportunities for professional growth and career advancement.
- A competitive salary package with additional benefits.
At our client, an international company in medical devices and pharmaceuticals, you can expect a market-based salary, an attractive bonus, and a range of additional benefits. We invest in your personal growth and career development. Ready to boost your career? Send in your CV today!
Myriam Van Londersele
Vacancy ID: 648
Sr. Staffing Manager Medical Devices | MedTech