The Company
We are currently supporting a highly specialised life sciences organization in the search for a Regulatory Affairs Specialist to join their team in Belgium.
Operating at the intersection of medical devices and pharmaceutical products, the company has built a strong reputation across Europe for delivering high-quality, patient-focused healthcare solutions. Their Regulatory Affairs function plays a key role in supporting global market access and ensuring compliance across an expanding international portfolio.
This is an excellent opportunity to join a collaborative, quality-driven environment where Regulatory Affairs is viewed as a strategic function within the business and where you will gain broad exposure across both medical devices and pharmaceuticals.
The Role
Reporting to the Senior RA Executive Manager, the successful candidate will support a broad range of regulatory activities across the full product lifecycle. This is a hands-on position offering strong ownership, cross-functional exposure, and involvement in both operational and strategic regulatory activities.
Key Responsibilities
* Prepare and manage regulatory submissions for medical devices and pharmaceutical products across relevant markets
* Create, maintain, and update Technical Documentation in accordance with EU MDR and applicable regulations
* Support ongoing compliance activities throughout the product lifecycle
* Assess the regulatory impact of change controls and perform gap analyses against new or updated standards, guidelines, and regulations
* Act as Person Responsible for Regulatory Compliance (PRRC) for Technical Documentation, subject to qualifications and training
* Own and maintain assigned regulatory processes, tracking systems, and quality-related records
* Represent Regulatory Affairs on cross-functional product and project teams
* Support communication with customers, competent authorities, and regulatory bodies where required
* Ensure all regulatory and quality documentation remains compliant, traceable, and audit-ready
Job Requirements
* Master’s degree in Physics, Chemistry, Biology, Pharmacy, or a related scientific discipline
* Alternatively, a Bachelor’s degree in Science combined with relevant industry experience will also be considered
Experience & Technical Knowledge
* 3–5 years’ experience within Regulatory Affairs in the medical device and/or pharmaceutical industry
* Strong understanding of:
* EU MDR / MDD
* ISO 13485
* GMP / GDP
* ICH Q guidelines
* Previous experience preparing regulatory submissions and/or authoring Technical Documentation
* PRRC qualification or eligibility would be considered a strong advantage
* Proficiency with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
Personal Profile
* Fluent in English, both written and spoken (essential)
* Strong attention to detail with a structured and methodical approach
* Able to manage multiple priorities within a fast-paced, deadline-driven environment
* Collaborative team player who can also work independently
* Proactive, solutions-oriented, and quality-focused
Interested in this position? Apply now!
✉ caustin@barringtonjames.com
☎ +44 (0) 1293 776644