Regulatory Affairs Lead - Medical Devices (FDA Expert)

Abiores; City Of London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A medical device company in the UK is seeking a Regulatory Affairs Specialist to support product registration and compliance with FDA regulations. The role requires a Bachelor's degree in Life Sciences and at least 2 years of experience in regulatory affairs. The successful candidate will interface with regulatory authorities, manage submissions, and collaborate with cross-functional teams to ensure business goals are aligned with regulatory strategies.

Qualifications

• Minimum 2 years of regulatory experience with the FDA on medical device submissions.
• Skills in project management and planning are required.
• Enthusiastic and accountable work ethic with strong interpersonal skills.

Responsibilities

• Support product registration activities and prepare registration dossiers.
• Act as the expert on FDA regulations and ensure compliance.
• Interface with global regulatory authorities and track submission progress.
• Participate in clinical verification and ongoing tracking activities.

Skills

Project Management

Technical Writing

Interpersonal Skills

Detail Orientation

Education

Bachelor's degree in Life Sciences

Job description

A medical device company in the UK is seeking a Regulatory Affairs Specialist to support product registration and compliance with FDA regulations. The role requires a Bachelor's degree in Life Sciences and at least 2 years of experience in regulatory affairs. The successful candidate will interface with regulatory authorities, manage submissions, and collaborate with cross-functional teams to ensure business goals are aligned with regulatory strategies.