About the position
To obtain and maintain regulatory approval and license in the global market for our diagnostic products and systems and thereby guarantee continued sales eligibility, we are looking to strengthen our R&D team with a Regulatory Affairs Manager.
In taking up this job you are responsible for the management of the registration and labelling strategy of our newly developed and established diagnostic products.
Your key tasks will be to:
- ensure world-wide licenses in line with applicable regulations for all existing and new products/systems;
- evaluate the regulatory environment and asses impact on new and existing regulatory files;
- provide guidance and advise to the organization regarding regulatory requirements;
- establish and maintain an ongoing dialogue with health authorities, notified bodies and other regulatory institutions;
- act as regulatory representative during internal and external audits;
- ensure the creation and adaptation of product labels, packaging and product master information in line with applicable internal procedures and external regulations;
- lead and coach the regulatory and labelling team members;
- ensure accurate and timely adverse event reporting to competent authorities.
- Master degree related to life sciences
- Knowledge of European, local IVD and medical devices legislation for all countries where Fujirebio Europe is selling is a must
- Experience in regulatory affairs, preferentially in diagnostics or medical devices
- Knowledge and experience with European regulatory submission
- Good understanding of applicable GxP regulations
- Good understanding of IVD development practices
- Excellent organization, interpersonal and communication skills
- Fluent in speaking and writing Dutch and English
Up for the challenge? We welcome your cv + motivation letter at firstname.lastname@example.org
By joining Fujirebio you contribute to a better healthcare in a company where different cultures meet each other which makes our jobs challenging and stimulating.
Our employees appreciate their rich job content and the great deal of independence within their job.
In an open, informal and dynamic work environment you will be collaborating with our scientific, commercial, operational and supportive teams. To support this collaboration and to support personal growth of all team members we offer our employees the opportunity to develop their knowledge, skills and talents.
Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative solutions for healthcare all over the world.
Our products and services allow doctors to make fast and accurate diagnosis in different disease fields like infectious diseases (f.e: Hepatitis C, HIV), neurological disorders (f.e. Alzheimer’s disease), oncology and genetic diseases (f.e. mucoviscidose). Based upon this specific an accurate testing, appropriate treatment can be started quickly.
We develop and manufacture diagnostic tests at our site in Ghent after which they are sold worldwide by our commercial teams to hospitals and clinical labs.
Furthermore, we use our advanced experience in development and manufacturing of Diagnostic solutions and our high-quality standards for contract manufacturing projects with third parties.
Fujirebio Europe belongs to an international group with branches and colleagues in Asia, Europe and the USA. We currently employ 130 people at the headquarters in Ghent and more than 40 people in our European affiliates.