ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.
This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.
All employees together form a large network of expertise, even at an international level. We are currently looking for a Regulatory Affairs (RA) Specialist to join our Life Sciences team in Belgium. As a Regulatory Affairs (RA) Specialist, you will ensure that products comply with applicable regulatory requirements and support the global registration, maintenance, and lifecycle management of our medical devices. Support CE marking and international registrations by preparing and coordinating submission dossiers for notified bodies, competent authorities, and international regulatory agencies.
MDR, MDCG guidance, ISO standards) to ensure ongoing compliance.
Partner with Quality, R&D, and Manufacturing teams to provide regulatory input in product development, changes, and lifecycle management projects.
Provide training and guidance on regulatory topics to cross-functional teams.
Degree in Pharmacy, Biological or Chemical Sciences, Biomedical Engineering, or related field.
Minimum of 3 years of experience in Regulatory Affairs within the medical device industry (experience in cardiovascular or sterile devices is a strong plus).
Solid knowledge of ISO 13485, EU MDR 2017/745, and related standards/guidance documents.
Experience with CE marking and preparation of technical documentation for Class II/III medical devices.
Strong communication and organizational skills, with ability to manage multiple projects and deadlines.
Fluent in both English and Dutch. French is an added value.
A permanent contract;
The possibility to join a great team and be part of the success story of an international group.
We are also open to work with freelancers!