Regulatory Affairs Officer

Euro London; Utrecht; Hybrid; EUR 50,000 - 65,000; Full time

Benefits offered by this job

8% holiday allowance

4% company bonus

€0.23/km commuting allowance or public

30 days annual leave

2 days WFH per week after onboarding

Job summary

Euro London is recruiting two Regulatory Affairs Officers to support a major regulatory programme for a medical device portfolio marketed across 35+ countries. You will operate in two complementary profiles: lifecycle regulation and registrations, collaborating with Quality, R&D and Operations.

Fluent English is required; Dutch is a plus. The roles offer long-term opportunities within a multinational regulatory team and include a competitive package with a fixed salary between €50,000 and

Qualifications

• Experience in Regulatory Affairs within the medical device industry.
• Experience with EU MDR Technical Documentation / Technical Files is a plus.
• English fluent; Dutch is a plus.

Responsibilities

• Maintain EU MDR Technical Documentation / Technical Files across the product lifecycle.
• Assess regulatory impacts of product, process, labeling and documentation changes.
• Prepare and maintain regulatory registration dossiers and track submissions.
• Coordinate with local representatives, authorities and internal stakeholders.

Skills

Regulatory Affairs

Medical Devices

Job description

Regulatory Affairs Officers – Two Positions

We are recruiting two Regulatory Affairs Officers to join an international medical device company and support a major regulatory programme covering a product portfolio marketed across 35+ countries.

The two positions sit within the same Regulatory Affairs team but have different areas of focus.

1. Regulatory Affairs Officer – Product Lifecycle

You will focus on maintaining the regulatory compliance of existing medical devices throughout their lifecycle.

Your responsibilities will include:

• Maintaining and updating EU MDR Technical Documentation / Technical Files.
• Assessing regulatory impacts of product, process, labelling and documentation changes.
• Supporting regulatory activities linked to evolving European requirements.
• Working closely with Quality, R&D, Operations and other internal teams.

You will focus on maintaining product registrations across international markets.

Your responsibilities will include:

• Preparing and maintaining regulatory registration dossiers.
• Managing registrations, renewals and change notifications.
• Tracking submissions across multiple countries.
• Maintaining accurate regulatory and product information.
• Coordinating with local representatives, authorities and internal stakeholders.

What are we looking for?

You should have practical Regulatory Affairs experience within the medical device industry and be able to work relatively independently.

Depending on the position, we are particularly interested in experience with:

• EU MDR Technical Documentation / Technical Files, including maintaining documentation throughout the product lifecycle; or
• International registrations, submissions, renewals and regulatory portfolio management.

You should also have:

• Fluent English. Dutch is a plus, and additional languages are welcome.

You do not need to cover both areas. We are looking for two complementary profiles, and your experience and interests will help determine which position is the best fit.

What can you expect?

• €50,000–€65,000 gross per year, including 8% holiday allowance.
• 4% company bonus.
• €0.23/km commuting allowance or full reimbursement of public transport.
• 30 days of annual leave
• Up to 2 days working from home per week after the first 3 months of onboarding.

Both positions offer long-term opportunities beyond the current regulatory programme, with exposure to wider regulatory, product and cross-functional projects.

Only candidates meeting the key requirements will be contacted.