Regulatory Affairs Specialist

12/07/22

Location

Blauwesteenstraat 87, Kontich, Belgium

Vacancy

Flen Health is an international family-owned company with ambitious pharmaceutical and medical device technology growth plans. 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 help people live the life they love by 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 companywide as Flen Health. As an intrapreneur, you will enjoy working in a diverse multicultural 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 Specialist to reinforce our team. This is a permanent full-time position which can be based in one of our 6 entities (LU-BE-NL-DE-UK-IRE) and report directly to our Regulatory Affairs Manager.

As Regulatory Affairs Specialist you will support the registration and the maintenance of all Flen Health products in the countries where the company commercializes its products in order to cope with the ISO standards and other regulations.

This position will suit you perfectly if you have a taste for challenges and the desire to make things happen.

 

 Your qualifications & experience:

  • You hold a Degree (Master and/or PhD) in Industrial Pharmacy/Pharmaceutical Sciences or equivalent scientific degree with equivalent experience

  • You demonstrate at least 3- 5 years of relevant experience in an equivalent role, ideally within the pharmaceutical industry

  • You have strong knowledge of regulatory affairs related to EU or FDA or other non-EU regulations

  • You are able to grasp new concepts quickly and assimilate and evaluate scientific data

  • You can easily read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information

  • You are fluent in both written and spoken English, other languages such as Dutch, French or German are an asset

  • You are able to prioritise tasks and adjust to sudden changes in workflow

  • You are experienced in Project Management and tools

Your responsibilities:

  • You support the Regulatory Affairs department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside the EU

  • You maintain product technical dossiers and other regulatory documents up to date during the lifecycle of Flen Health’s products

  • You maintain a Quality system and procedures

  • You ensure that Flen Health is compliant and maintain the CE and ISO certificate requirements

  • You participate in the implementation of the new Medical Device Regulation within Flen Health

  • You ensure the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen Health’s products, in close collaboration with marketing and sales

  • You always be kept up to date with the necessary training 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 of Regulatory Affairs

What we offer:

  • Excellent working conditions

  • An innovative and inspiring work environment

  • Independent project work & responsibilities within a professional team

  • Career prospect

  • Learning and development opportunities

  • Competitive remuneration according to experience  

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

Please send your application, CV and motivation letter to the following email address: recruitment@flenhealth.com

Job application