Flen Health is an international, innovative, family-owned company based in Luxembourg, Belgium, the Netherlands, Germany and the UK.
Over the course of just a few years, Flen Health have gained the leading position in their home market, namely the Belgian wound care market and are working towards achieving this on an international level. Our company’s success is based on the dedication of our people and our safe and easy-to-use product portfolio which combines innovation with significant progress in wound care and is inspired by our motto. We help you to ‘live the life you love’.
We are looking for a fulltime Regulatory Affairs Specialist, for immediate start at our headquarter based in Esch-sur-Alzette (Luxembourg) or Kontich (Belgium).
Your qualifications & experience:
- You support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU
- You support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of Flen’s products
- You participate in the implementation of the new Medical Device Regulation within Flen
- You ensure the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen’s products, in close collaboration with marketing and sales
- You keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
- You identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
- You work in close collaboration with and report to the Manager Regulatory Affairs
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience.
- At least two years of professional experience in Regulatory Affairs for medical devices
- Experience in international regulatory affairs is required; knowledge of regulatory affairs related to FDA and other non-EU regulations also
- Project management knowledge is an asset
- Familiar with MS Office and database applications
- English is mandatory; Strong communication skills both written and verbal
- Excellent planning and organisational skills
- Quality minded
- Strong interpersonal skills
- Problem solving ability
- Strong analytical ability
Work at Flen Health:
Flen Health is a young and fast-growing, independent organization with short communication lines, and where entrepreneurship is appreciated. Its products are innovative, patented and are well regarded by the key opinion leaders internationally.
Several highly motivated and enthusiastic colleagues have already joined Flen Health and contribute to its success. As an expending company, we offer possibilities for personal development and growth.
Are you interested in working with an ambitious and highly dedicated team?
Please send your CV and covering letter by using the form below: