Principal Regulatory Affairs Specialist – EMEA

About the role

The Principal Regulatory Affairs Specialist will provide expert regulatory support across the UK&I, BeNeLux and Nordic clusters, guiding products from concept through launch and post‑market. You will lead the development and implementation of regulatory strategies and ensure compliance with regional regulations.

Key responsibilities

• Review and approve regulatory documents for new and existing products in assigned EMEA markets.
• Maintain and update submission dossiers, databases and regulatory files, ensuring timely access to accurate information.
• Monitor regional registration requirements and communicate changes to management and business partners.
• Establish and manage relationships with government agencies, regulatory bodies and trade associations.
• Review technical files for CE approval and support Notified Body inquiries.
• Participate in technical audits, including preparation, response and close‑out activities.
• Provide regulatory input on product labeling, IFUs and support “Own Brand” and private‑label customers.
• Coach and mentor junior regulatory team members.

Required profile

• Extensive experience in regulatory affairs for medical devices within the UK, EU, BeNeLux and Nordic regions.
• Strong knowledge of CE marking, UK MDR, EU MDR and related national regulations.
• Proven ability to develop and execute regulatory strategies for multi‑market product launches.
• Excellent communication skills to liaise with internal teams and external authorities.
• Leadership experience in mentoring junior staff.

Required skills

• CE marking and regulatory submission processes.
• Technical file preparation and review.
• Interaction with Notified Bodies and regulatory agencies.
• Regulatory database management.

What we offer

• Competitive salary and benefits package.
• Opportunity to work across multiple EMEA markets.
• Professional development and mentorship.