Regulatory Affairs Associate – Medical Device Ireland

Resourcing Life Science; Ireland; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading firm in life sciences is seeking an experienced Regulatory Affairs professional in Ireland. The successful candidate will conduct regulatory impact assessments, manage registrations and collaborate with global partners. Ideal applicants will possess a Bachelor degree and a minimum of 4 years of experience in Regulatory Affairs, particularly in the medical device sector. Fluent communication in English is essential. This role offers opportunities for professional growth within a dynamic environment.

Qualifications

• Minimum 4 years of experience in Regulatory Affairs, particularly in the medical device sector.
• Fluent in English (written and spoken).

Responsibilities

• Conduct regulatory impact assessments for product changes.
• Manage annual registrations and license renewals.
• Coordinate data collection for international regulatory registrations.

Skills

Regulatory submissions

Communication skills

Problem-solving skills

Collaboration

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]