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 Manager who, in close collaboration with the VP of R&D, will be responsible to guide and coordinate regulatory matters of Flen Health to ensure that the company’s products are in compliance with regulations and standard operating procedures in existing countries where the focus is on EU and medical devices and in new countries where a focus is on the FDA and biologics. 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
- 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
- Be in charge of Flen Health’s product registration submissions, such as, but not limited to technical files (CE marking of medical devices) and other regulatory documents in collaboration with quality department where needed
- Advise in market access strategies and Pharmacoeconomics
- Be responsible for compliance with the ethical codes of conduct and of transparency guidelines related to Flen Health products and fields of activity integrating ethical codes from legislative bodies and Flen Health vision on ethical conduct in collaboration with HR
- Manage reimbursement files in close collaboration with the Sales and Marketing departments
- Serve as an internal resource to address and resolve any questions or issues of a regulatory nature
- Conduct due diligence investigations and reporting to the relevant authorities in accordance with applicable legislation and the company's standard operating procedures.
- Ensure that the company maintains 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
- 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 Director of Regulatory Affairs
Your qualifications & experience:
- Graduated (Bachelor/Master’s degree/PhD) in Industrial Pharmacy/Pharmaceutical Sciences or related scientific background
- 3 to 5 years professional experience in international regulatory affairs in a pharmaceutical / medical device environment
- Strong 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
- Ability to train and develop team members by proving coaching and sharing experiences and best practices with them
- 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?
Please send your CV and covering letter by using the form below: