ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.
In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. 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. In this way we offer optimal growth to our consultants and the best solutions for our customers.
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. You will act as a key link between company, regulatory authorities, and notified bodies, ensuring timely submissions and approvals for products.
Key responsibilities
* Prepare, review, and maintain regulatory documentation (e.g., technical files, declarations of conformity, clinical evaluations) in line with Regulation (EU) 2017/745 (MDR) and ISO 13485 requirements.
* Support CE marking and international registrations by preparing and coordinating submission dossiers for notified bodies, competent authorities, and international regulatory agencies.
* Monitor and interpret regulatory requirements, standards, and guidance (e.g., MDR, MDCG guidance, ISO standards) to ensure ongoing compliance.
* Act as regulatory contact during audits and inspections by notified bodies and competent authorities.
* Partner with Quality, R&D, and Manufacturing teams to provide regulatory input in product development, changes, and lifecycle management projects.
* Maintain regulatory databases, product registrations, and certificates, ensuring accuracy and timely renewals.
* Contribute to vigilance activities by assessing regulatory impact of complaints, adverse events, and CAPAs.
* Provide training and guidance on regulatory topics to cross-functional teams.
Qualifications
* 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.
* Experience interacting with notified bodies and regulatory authorities is considered a strong plus.
What ALTEN has to offer
* A permanent contract;
* A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances);
* 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!
Apply now and be a part of our amazing journey. We believe in growing together!
We are looking forward to getting to know you and your ambitions!