Our client is a Belgian company active in the in-vitro diagnostics sector.
They are specialists in immunoassay development, manufacturing and distribution since more than 25 years, with a specialization in Vitamin D. They serve customers in over 70 countries, both direct as through our network of distributors and OEM partners.
The company of 80 employees is based south of Brussels (Belgium/Louvain-la-Neuve) close to the University (UCL).
In the light of the growth and development of our company, we are recruiting a Regulatory Affairs (RA) officer for our offices in Louvain-la-Neuve.
The Regulatory Affairs (RA) officer ensures the appropriate licensing, marketing and legal compliance of our medical products in order to control the safety and efficacy of it.
He/She combines his/her knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured and distributed by a wide range of companies, meet the required legislation.
The Regulatory Affairs is the crucial link between the company, its products and regulatory authorities worldwilde.
- Ensuring that DIAsource’s products comply with the regulations;
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- Developing and writing clear arguments and explanations for new product licenses and license renewals;
- Maintaining professional relationships with the regulatory authorities for the registration of new products;
- Coordinating and implementing the product registration plan, incl. coordination of the prioritization of registration pipeline needs and proposals;
- Preparing submissions of license variations and renewals to strict deadlines;
- Monitoring and setting timelines for license variations and renewal approvals;
- Advising scientists and manufacturers on regulatory requirements;
- Continuously updating of relevant regulatory guidelines and knowledge.
- Bachelor or Master degree in scientific discipline ;
- Experience not strictly required, but knowledge in regulatory and/or medical device business is an obvious plus.
- Excellent to good mastery of spoken and written English is a key requirement, French is needed as operational language.
- Process oriented and rigorous;
- Self-organized and autonomous;
- Good written and verbal communication skills;
- Team player;
- Efficient in use of IT systems;
Our client’s offer
- A stimulating central position within a high‐growth middle size biotech company ;
- A job in a human-sized, dynamic, respectful and professional environment ;
- Many training opportunities for your personal development and your continuous improvement.