Regulatory Affairs Specialist EMEA

About the role

Integra LifeSciences is seeking a Regulatory Affairs Specialist to support product registrations and market access across the EMEA region. You will work closely with business divisions, tender teams, and marketing to ensure regulatory compliance and timely approvals.

Key responsibilities

• Plan, coordinate and maintain product registrations to meet EMEA business objectives.
• Prepare and update submission files for CE mark, UKCA, Swiss, Egypt, Saudi Arabia, Morocco, Algeria and other regional certifications.
• Secure regulatory conformity for EMEA sales entities and keep registration indicators up‑to‑date.
• Evaluate product and manufacturing changes for regulatory impact.
• Act as the regulatory point of contact for tender teams and support market‑access activities, including distributor agreements and reimbursement processes.
• Review and approve promotional materials in line with local regulations and company policies.
• Conduct regulatory intelligence on EMEA regulations and escalate issues to senior management.
• Provide training on regulatory requirements and generate regular reports.

Required profile

• Pharmacist, Biomedical Engineer, or Master’s degree in Regulatory/Quality.
• Minimum 3 years experience in Regulatory Affairs within the pharmaceutical or medical‑device industry.
• Strong knowledge of European Medical Devices Directives, EU MDR 2017/745, UK MDR 2002, UKCA, MedDO, and 21 CFR Part 820.
• Project‑management experience and ability to work autonomously.
• Fluent English communication skills.

Required skills

• EU Medical Devices Directive 93/42/EEC
• EU Medical Devices Regulation 2017/745 (MDR)
• UK MDR 2002 and UKCA
• MedDO
• 21 CFR Part 820
• Regulatory intelligence and compliance
• Project management

What we offer

• Opportunity to work on international product registrations.
• Collaboration with cross‑functional teams across EMEA.
• Professional development in regulatory affairs.