Global Regulatory Affairs Specialist - Medical Devices

EPM Scientific; Brussel Hoofdstad; On-site; EUR 55,000 - 90,000; Full time

Job summary

EPM Scientific in Belgium seeks a Regulatory Affairs Specialist to support market access, product lifecycle management, and compliance across EMEA. You will collaborate with Regulatory Affairs, Quality Assurance and Compliance teams, manufacturers, distributors and regulatory authorities to ensure devices remain compliant and available across assigned territories.

This role requires a life sciences background, strong organizational skills, and fluent English, with additional European languages

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or related discipline.
• Experience in regulatory affairs within the medical device industry.
• Understanding of medical device regulations and international registration processes.
• Experience supporting product registrations, regulatory submissions and lifecycle management.
• Excellent stakeholder management and communication skills.

Responsibilities

• Coordinate regulatory submissions and market access across multiple markets.
• Maintain registration dossiers and ensure regulatory timelines are met.
• Support compliance obligations for medical device and IVD products.
• Review product changes and ensure appropriate approvals and documentation.
• Provide regulatory guidance to support business decisions and training.

Skills

Regulatory coordination

Project coordination

Stakeholder management

Fluent English

Education

Bachelor's degree in Life Sciences or related

Job description

EPM Scientific in Belgium seeks a Regulatory Affairs Specialist to support market access, product lifecycle management, and compliance across EMEA. You will collaborate with Regulatory Affairs, Quality Assurance and Compliance teams, manufacturers, distributors and regulatory authorities to ensure devices remain compliant and available across assigned territories.

This role requires a life sciences background, strong organizational skills, and fluent English, with additional European languages