Regulatory Affairs Specialist F / M - Belgium or Luxembourg
Belgium or Luxembourg, - full-time - 09.09.2021

 

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 are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.

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 company-wide 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 eco-system, enthusiastic colleagues, and an attractive remuneration package.

We are looking for a Regulatory Affairs Specialist to handle, in close collaboration with the other members of the RA team, the Regulatory Affairs Department concerning the registration and the maintaining of all Flen Health products in the countries where Flen Health commercializes its products in order to cope with the ISO standards and other regulations. The Regulatory Affairs Specialist will advise on legal and scientific restraints and requirements which means collecting, collating and evaluating scientific data. This full-time and permanent position will be located in Belgium or in Luxembourg.

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

Your responsibilities:

  • Take an active part in the good running of the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU
  • Support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of Flen’s products
  • Help to be compliant and to maintain the CE and ISO certificate requirements
  • Participate in the implementation of the new Medical Device Regulation within Flen
  • Support the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen’s products, in close collaboration with marketing and sales
  • Attend relevant courses (internal and external) to further expand current knowledge of regulatory affairs related to EU or FDA and or non-EU regulations and willing to keep your knowledge updated by self-education/ training
  • Keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
  • Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
  • Work in close collaboration with and report to the Manager of Regulatory Affairs

Your qualifications & experience:

  • Graduated (Bachelor/Master’s degree/PhD) in Industrial Pharmacy/Pharmaceutical Sciences or related scientific Master
  • 2 years professional experience in international regulatory affairs is required
  • Willing to acquire knowledge of regulatory affairs related to EU or FDA or other non-EU regulations
  • Ability to read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information
  • Strong time and project management skills/knowledge is an asset
  • Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.), experience in Data capturing tools is a plus
  • Knowledge of QMS system and PMS Salesforce or equivalent would be appreciated
  • Self-motivated team worker
  • Share recommendations, experiences and best practice with colleagues
  • Creating enthusiasm and initiative to make things happen
  • Listening to others and giving constructive feedback
  • Fluency in English, both written and spoken, other languages as French, Dutch or German are an asset

Are you interested in working with an ambitious and highly dedicated team?

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