Regulatory Compliance Specialist - Medical Device

Michael Page (UK); Manchester; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading medical devices manufacturer is seeking a Regulatory Affairs Compliance Specialist to ensure compliance with FDA regulations. The role involves managing regulatory submissions, liaising with external bodies, and providing training to staff. Candidates should have a degree in Life Sciences and proven experience in regulatory affairs.

Qualifications

• Proven experience in regulatory affairs.
• Solid understanding of FDA regulations and guidelines.
• Ability to manage multiple projects simultaneously.

Responsibilities

• Ensuring compliance with FDA regulations and standards.
• Managing all regulatory submissions and documentation.
• Providing training and support to staff on regulatory issues.

Skills

Communication

Organisational Skills

Attention to Detail

Problem Solving

Education

Degree in Life Sciences or related field

Job description

• Fantastic opportunity to join a leading medical devices manufacturer
• Fantastic opportunity to work with NPD lines

About Our Client

My client is a leading medical device manufacturer within the beauty/tech space with innovative new product development lines and existing portfolio.

Job Description

Ensuring compliance with FDA regulations and standards.

Managing all regulatory submissions and documentation.

Liaising with external regulatory bodies.

Coordinating with internal teams to ensure company-wide compliance.

Staying up-to-date with changes in regulatory legislation and guidelines.

Contributing to the development of regulatory strategies.

Providing training and support to staff on regulatory issues.

Participating in audits and inspections.

The Successful Applicant

A successful Regulatory Affairs Compliance Specialist should have:

• A degree in Life Sciences or a related field.
• Proven experience in regulatory affairs.
• A solid understanding of FDA regulations and guidelines.
• Excellent communication and organisational skills.
• The ability to manage multiple projects simultaneously.
• Strong attention to detail and problem-solving abilities.

What's on Offer

Competitive package available