Global Regulatory Affairs Associate for Medical Devices

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

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.