Regulatory Specialist

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

Regulatory Affairs Specialist - Medical Devices

Industry: Medical Devices / Medical Equipment Manufacturing

About the Role

An established international medical device organisation is seeking a Regulatory Affairs Specialist to support regulatory market access, product lifecycle management, and compliance activities across multiple EMEA markets.

Working within a collaborative Regulatory Affairs, Quality Assurance and Compliance team, you will partner with manufacturers, distributors, commercial teams and regulatory authorities to ensure products remain compliant and available across assigned territories.

Key Responsibilities

Regulatory Submissions & Market Access

• Coordinate and manage regulatory registrations across multiple international markets.
• Prepare and maintain registration dossiers, ensuring submissions meet local regulatory requirements and timelines.
• Liaise with manufacturers, distributors, commercial teams and regulatory authorities to support registration activities.
• Maintain regulatory documentation and ensure records remain current and audit ready.
• Support ongoing compliance obligations related to medical device and IVD products.

Product Lifecycle Management

• Assess and coordinate regulatory activities associated with product changes.
• Review change notifications and ensure appropriate internal stakeholder approval.
• Maintain oversight of product change documentation and implementation activities.
• Support regulatory review of product claims, labelling and marketing materials.
• Monitor evolving medical device and IVD regulations.
• Interpret new regulatory requirements and communicate impacts to key stakeholders.
• Provide practical regulatory guidance to support business decision-making.
• Build relationships with relevant industry and regulatory stakeholders.
• Participate in process improvement initiatives across Regulatory Affairs and Quality functions.
• Identify regulatory risks and opportunities to strengthen compliance processes.
• Share regulatory knowledge and support internal training activities.
• Contribute to broader team objectives and cross-functional projects.

Requirements

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related discipline.
• Previous Regulatory Affairs experience within the medical device industry.
• Understanding of medical device regulations and international registration processes.
• Experience supporting product registrations, regulatory submissions and lifecycle management activities.
• Strong project coordination and organisational skills.
• Ability to manage multiple priorities in a fast-paced international environment.
• Excellent stakeholder management and communication skills.
• Fluent English required; additional European languages are beneficial.
• Analytical, detail-oriented and proactive approach to problem solving.
• Strong interest in regulatory compliance and continuous professional development.