Regulatory Affairs – Netherlands

Resourcing Life Science; Netherlands; On-site; EUR 90,000 - 120,000; Full time

Job summary

Resourcing Life Science in the Netherlands is seeking an experienced Regulatory Affairs professional to lead global regulatory submissions for medical devices. You will manage timelines, prepare EU MDR documentation, and liaise with authorities and distribution partners to secure market access.

You will act as regulatory representative on cross-functional teams, interpret international regulations, and ensure labeling and product changes stay in compliance across markets.

Qualifications

• Minimum 5 years of regulatory experience in medical devices.
• Fluent English required for global collaboration.

Responsibilities

• Establish and manage global regulatory submission timelines.
• Prepare and file global medical device applications and amendments.
• Engage with regulatory authorities and distribution partners to support registrations.
• Author EU MDR-compliant technical documentation and lead EU regulatory initiatives.
• Conduct regulatory impact assessments for product and manufacturing changes.
• Represent regulatory on cross-functional teams to embed requirements.
• Interpret and apply international regulations and directives for compliance.
• Review and approve labeling to meet regulatory requirements.
• Support inspections and audits by global regulatory authorities.

Skills

Minimum 5 years of Experience

Fluent English

Job description

What to Expect

• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partnersto support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
• Review and approve product labelingto ensure compliance with global regulatory requirements.
• Support and participate in inspections and auditsconducted by global regulatory authorities.

Responsibilities

• Minimum 5 years of Experience
• Fluent English