Global Regulatory Affairs Leader — Medical Devices (Hybrid)

Cambridge Heartwear; United Kingdom; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A cutting-edge medical technology firm based in Cambridge is seeking a dedicated Regulatory Manager. This role involves leading regulatory strategies and ensuring compliance with medical device regulations. The ideal candidate will have a background in quality assurance and at least 5 years of experience in the medical devices industry. Key responsibilities include preparing regulatory submissions, managing audits, and liaising with regulatory agencies. Offering a hybrid working model, this is an opportunity to make a significant impact in innovative healthcare solutions.

Benefits

Company pension

On-site parking

Work from home

Qualifications

• Minimum 5 years of experience in quality assurance or quality management in the medical devices industry.
• In-depth knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820.
• Proven ability to manage CAPA, NCRs and quality investigations.

Responsibilities

• Lead and execute global regulatory strategies for new product development.
• Prepare and submit regulatory dossiers and license renewals.
• Monitor and interpret evolving regulatory requirements.

Skills

Communication skills

Leadership skills

Analytical skills

Problem-solving abilities

Knowledge of SaaMD

Education

Bachelor's degree in Life Sciences, Quality Assurance or related field

Quality certification (CQE, CQA, Six Sigma or equivalent)

Tools

QMS software

Microsoft Office Suite

Job description

A cutting-edge medical technology firm based in Cambridge is seeking a dedicated Regulatory Manager. This role involves leading regulatory strategies and ensuring compliance with medical device regulations. The ideal candidate will have a background in quality assurance and at least 5 years of experience in the medical devices industry. Key responsibilities include preparing regulatory submissions, managing audits, and liaising with regulatory agencies. Offering a hybrid working model, this is an opportunity to make a significant impact in innovative healthcare solutions.