Regulatory Affairs Officer

Regulatory Affairs Officers –  Two positions

Utrecht area | Hybrid working | Full-time

Do you have experience in Regulatory Affairs within the medical device industry and enjoy working in an international environment?

Our client is an international company operating within the medical device industry.

We are currently recruiting two Regulatory Affairs Officers to join the same Regulatory Affairs team and support a major regulatory transition programme involving an international product portfolio marketed across more than 35 countries.

The two positions are complementary and will have different areas of focus:

1. Regulatory Affairs Officer – Product Lifecycle

This position will focus primarily on maintaining the regulatory compliance of existing products throughout their lifecycle.

Key activities will include:

• Supporting regulatory changes relating to existing products.
• Maintaining Technical Files and regulatory documentation.
• Assessing the regulatory impact of product, labelling and documentation changes.
• Supporting activities linked to evolving European regulatory requirements.
• Working closely with Quality, R&D, Operations and other internal stakeholders.

2. Regulatory Affairs Officer – Registration & Portfolio Management

This position will focus primarily on ensuring products are registered, renewed and maintained across international markets.

Key activities will include:

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

What are we looking for?

For both positions, you should already have practical Regulatory Affairs experience and be comfortable contributing relatively independently from the start.

Ideally, you will bring:

• Previous experience in Regulatory Affairs within the medical device industry.
• Experience relevant to either product lifecycle and technical documentation or international registrations and regulatory submissions.
• A relevant degree in life sciences, chemistry, quality or a related field.
• Strong organisational and communication skills.
• Fluent English – Dutch is a plus and any additional language is an asset.

You do not necessarily need to match both areas of expertise. We are looking for two complementary profiles, and your background along with your preference will help determine which position is the best fit.

What can you expect?

• A yearly salary between €50,000 and €65,000, including holiday allowance, depending on experience and expertise.
• Company bonus: 4% of annual salary, based solely on company performance.
• Pension plan: Defined Benefit Plan (Middelloonregeling), with an 8% employee contribution.
• Transportation allowance: €0.23 per kilometre for commuting distances between 10 km and 75 km, or 100% reimbursement of public transport costs.
• 30 days of annual leave.
• Hybrid working: Up to 2 days per week working from home following the first 3 months of onboarding and subject to agreement with the manager.

Both positions are designed as long-term career opportunities. Beyond the current regulatory programme, you will have the opportunity to contribute to wider regulatory, product and cross-functional projects within the organisation.

Please send your English-language CV to t.perriaux@eurolondon.com for a confidential discussion.

View all our current vacancies at www.eurolondon.fr

Only candidates who meet the key requirements of the positions will be contacted.