Manager, Regulatory Affairs
* Location: Brussels, Belgium - Full Time
* Reports To: Senior Manager, Regulatory Affairs Department
* Start Date: As soon as possible
Why MedTech Europe
MedTech Europe is the European trade association for the medical technology industries. Join us to help shape a predictable, innovation-friendly and well governed regulatory environment so patients across Europe get timely access to safe, effective technologies.
The role in one line
Lead member-facing work on EU Medical Devices Regulation (MDR 2017/745) within the Regulatory Affairs team, turning complex regulation into practical guidance and policy impact.
What you will do
* Drive MedTech Europe working groups (e.g., Notified Body, Standards, Blood Tissues and Cells etc.) to clear deliverables and consensus positions
* Coordinate borderline topics between medical technologies and medicinal products
* Analyse horizontal and/or evolving legislation affecting the sector (e.g., MDR revision) and brief members
* Draft and coordinate responses to consultations; prepare positions, briefings and presentations; support advocacy with EU stakeholders
* Develop industry guidance for members on MDR implementation, and where relevant align with IVDR 2017/746
* Represent MedTech Europe in meetings with EU institutions, policymakers and stakeholders; liaise with peer associations in Brussels
What you bring (essentials)
* University degree in a relevant field (e.g. Biomedical Engineering, another scientific discipline, European Studies, Law, Political Science, Healthcare Economics)
* Minimum 5 years of experience in the medical technology ecosystem (industry, Notified Body, or EU institution)
* Solid understanding of EU institutions and policymaking processes
* Excellent written and spoken English, with strong facilitation, communication and stakeholder-management skills
* Proven ability to synthesise and present complex legal and technical material with clarity and depth
* Highly organised and reliable, able to manage deadlines, lead meetings and work independently or in cross-functional/hybrid teams
* Strong sense of ownership and accountability: anticipates issues, proposes solutions proactively, and delivers consistent, high-quality results
* Proficient in MS Word, Excel, PowerPoint and Outlook
Nice to have
* Association/membership-based organisation experience
* Collaboration with EU institutions on regulatory files
* Experience in multicultural environments; additional EU languages
What we offer
* A permanent full-time work contract (39h/week) under Belgium law
* Competitive salary package, including benefits such as lunch vouchers, pension plan, full medical plan, reimbursement of public transport, mobile phone subscription
* Mission-driven work with Europe-wide impact
* Collaborative, international team culture and exposure to senior EU stakeholders
* Professional development budget and learning opportunities
* Possibility of homeworking 2 days/week
* Travel: occasional EU and international
How to apply
Email your CV (max 2 pages) and a motivation letter (≤250 words) with subject line: “Manager Regulatory Affairs Application: YOUR NAME”.
Your letter should cover:
1. Why this role;
2. What relevant knowledge and skills you bring to MedTech Europe.
Notes
* Applications not addressing the two questions will not be considered
* Interviews will take place on a rolling basis
* Only shortlisted candidates will be contacted (interviews may be remote)
* Early applications may be reviewed before the deadline; quality over speed
Applications should be sent to: regulatory@medtecheurope.org by 31 October 2025 latest.