Regulatory Affairs Associate – Medical Device Denmark

Resourcing Life Science; Denmark; On-site; DKK 600,000 - 800,000; Full time

Job summary

A leading regulatory consulting company in Denmark seeks an experienced professional in Regulatory Affairs. The role involves conducting regulatory impact assessments, managing annual registrations, and supporting FDA dossiers preparation. The ideal candidate will have a Bachelor's degree and at least 4 years of experience in the medical device industry, along with strong communication skills. This position is located in Denmark and offers an opportunity to work within a global team.

Qualifications

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

Responsibilities

• Conduct regulatory impact assessments for product changes.
• Manage annual registrations and license renewals.
• Support the preparation and submission of FDA dossiers.

Skills

Excellent communication

Problem-solving skills

Regulatory knowledge

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]

Tagged as: Regulatory Affair