Regulatory Affairs Associate – Medical Device Netherlands

Resourcing Life Science; Netherlands; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading life sciences consultancy in the Netherlands seeks a Regulatory Affairs professional with a Bachelor’s degree and a minimum of 4 years of experience in medical devices. The role involves conducting regulatory impact assessments, managing registrations, and supporting FDA submissions. Excellent communication and problem-solving skills are essential, along with fluency in English. This is a chance to collaborate with global teams to ensure compliance and timely submissions.

Qualifications

• Minimum 4 years of experience in Regulatory Affairs, preferably in medical devices.
• Proven experience with global submissions, including FDA.

Responsibilities

• Conduct regulatory impact assessments for product changes.
• Manage annual registrations and license renewals.
• Support preparation and submission of FDA dossiers.
• Coordinate data collection for international registrations.
• Collaborate with global Regulatory Affairs partners.
• Execute documentation and procedural activities.

Skills

Regulatory impact assessments

Excellent communication

Problem-solving skills

Fluent in English

Education

Bachelor degree

Job description

What to Expect

• Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
• Manage annual registrations, license renewals, and ongoing regulatory notifications.
• Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
• Coordinate the collection, review, and consolidation of data for international regulatory registrations.
• Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
• Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function.

Requirements

• Bachelor degree
• Min 4 years of experience in Regulatory Affairs in the medical device
• Proven experience with global submissions, preferably including FDA,
• Excellent communication and problem-solving skills
• Fluent in English (written and spoken).

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]