Regulatory Affairs Associate – Medical Device United Kingdom

Resourcing Life Science; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading regulatory consultancy in the United Kingdom is seeking an experienced Regulatory Affairs professional to manage compliance with FDA and international regulations. The ideal candidate will have a Bachelor's degree and a minimum of 4 years' experience in the medical device sector. Responsibilities include conducting regulatory impact assessments, managing annual registrations, and preparing FDA dossiers. Candidates must have excellent communication skills and be fluent in English.

Qualifications

• Min 4 years of experience in Regulatory Affairs in the medical device sector.
• Proven experience with FDA submissions.

Responsibilities

• Conduct regulatory impact assessments for product changes.
• Manage annual registrations and license renewals.
• Prepare and maintain FDA dossiers and related documentation.
• Coordinate data collection for international registrations.
• Collaborate with cross-functional stakeholders for compliance.
• Execute administrative activities supporting Regulatory Affairs.

Skills

Regulatory impact assessments

Global submissions

Communication skills

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]