Regulatory & Quality Compliance Lead

Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.

At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.

At Flen Health, we expect you to show grit, take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem, enthusiastic colleagues, and an attractive remuneration package.

We are looking for a
Regulatory & Quality Compliance Senior Specialist
for an immediate start to strengthen our team. This is a permanent full-time position located in our office in Kontich, Belgium.

In this hybrid role, you will play a pivotal part in shaping regulatory strategies while contributing to key quality process ownership and integration projects. This newly created position aimed at strengthening cross-functional collaboration between RA and QA, and to proactively support compliance and operational excellence as we expand and mature our quality system.

This position would suit you perfectly if you are driven by a desire to improve patients' health and have the desire to make things happen.

Your responsibilities:

Regulatory Affairs

• Develop and implement regulatory strategy for our product portfolio for your dedicated region
• Managing regulatory submission to authorities
• Staying up-to-date on regulatory changes and as such ensuring continued compliance with regulations
• Serve as the main contact point for local competent authorities and distributors

Quality Affairs

• Ensuring product meet established standards
• Act as SME for key QA processes including feedback, non-conformances and CAPAs
• Serve as trainer for these processes, providing guidance and ensuring effective cross-functional understanding and application.
• Conduct internal and external audits
• Drive internal QA projects (e.g., audit preparations, MDSAP readiness)
• Drive RA/QA interface improvements

Your qualifications & experience:

• Master's degree Life Sciences, Pharmacy, or a related field or a proven track record in the related field
• Minimum of 10 years of experience in Regulatory Affairs and Quality Assurance within medical devices or a closely related life sciences industry (pharmaceutical experience is a plus)
• Strong knowledge of ISO 13485, MDR
• Experienced in deviation management and training your colleagues
• Excellent cross-functional communication skills and a collaborative, solution-oriented mindset
• Ability to analyse and interpret technical documents, regulatory guidelines, and quality standards
• Problem-solving mindset with a proactive approach to quality improvement
• Fluency in English is required; proficiency in Dutch and/or French is a plus

What we offer:

• Excellent working conditions
• An innovative and inspiring work environment
• Independent project work & responsibilities within a professional team
• Career prospects
• Learning and development opportunities
• Competitive remuneration according to experience