Global Medical Device Regulatory Affairs Associate

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

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.