Regulatory Affairs Manager (M/W/D)

BE, Kontich - Fulltime

Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device markets. We have 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, to 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 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 Affairs Manager for an immediate start to reinforce the RA department. This is a permanent full-time position based in our office in Belgium, Kontich. As Regulatory Affairs Manager, you will be responsible for driving, guiding and coordinating regulatory affairs activities of the organization related to non-affiliate country registrations and support these in affiliate countries. This position will suit you perfectly if you have a taste for challenges and the desire to make things happen!

What we offer:

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

Your responsibilities:

• You will develop and implement regulatory strategies that ensure that products, procedures and policies meet and continue to meet applicable regulations in the countries where Flen Health commercializes its products. The initial focus will be on non-affiliate countries (currently over 30 countries worldwide).
• You will be responsible for Flen Health’s product registration submissions, such as, but not limited to technical files (E.g. medical devices and Biopharma) and other regulatory documents in collaboration with other departments (e.g. Export, R&D, Quality,…) where needed.
• You will serve as an internal resource to address and resolve any questions or issues of a regulatory nature (direct: non-affiliate; indirect: affiliate).
• You will support reimbursement files from a regulatory point of view in close collaboration with the Market access.
• You will handle the investigation of vigilance cases and report to the relevant authorities according to applicable legislation and company SOPs.
• You can act as a Person Responsible for Regulatory Compliance or as a backup in the regulatory regions related to your role.

Your qualifications & experience:

• You have graduated (e.g. PhD, Master's degree) in medicine/pharmacy or other healthcare-related university degree.
• You demonstrate at least 5 years of working experience in the field of regulatory affairs in a pharmaceutical and medical device environment, preferably within different regulatory regions.
• You have gained proven successful experience in managing, both remote and on-site, different internal/external stakeholders in achieving regulatory success in non-EU countries.
• You possess strong knowledge of regulatory affairs related to FDA or other non-EU regulations.
• You have in-depth knowledge of applicable laws and standards such as ISO13485, MDSAP, GxP, PRRC and PMS.
• You have the ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
• You are able to read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information.
• You are familiar with the regulatory side of the QMS system and technical dossier requirements.
• You demonstrate good Project Management skills
• You are fluent in English, oral and written. Other languages such as Dutch, German or French are an asset.