Manager Regulatory Affairs

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.