Global Regulatory Affairs Specialist: FDA & EU MDR

Aurora Lifesciences; South Yorkshire; On-site; GBP 40,000 - 60,000; Full time

Job summary

A medical device company in South Yorkshire is seeking a Regulatory Affairs Specialist to support global regulatory strategies and ensure compliance with FDA and EU MDR frameworks. The role involves managing regulatory filings, ensuring compliance, and collaborating across teams. The ideal candidate will have 3–5 years of regulatory affairs experience in the medical device industry, strong communication skills, and a solid understanding of applicable standards.

Qualifications

• Bachelor’s degree in a relevant field; Master’s preferred.
• Minimum 3–5 years of regulatory affairs experience.
• Hands-on experience with FDA submissions and EU MDR technical documentation.

Responsibilities

• Support preparation, submission, and maintenance of regulatory filings.
• Ensure compliance with EU MDR requirements.
• Manage post-market activities such as vigilance reporting.

Skills

Regulatory affairs experience

Communication skills

Problem-solving skills

Team collaboration

Education

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs

Tools

ISO 13485

ISO 14971

Job description

A medical device company in South Yorkshire is seeking a Regulatory Affairs Specialist to support global regulatory strategies and ensure compliance with FDA and EU MDR frameworks. The role involves managing regulatory filings, ensuring compliance, and collaborating across teams. The ideal candidate will have 3–5 years of regulatory affairs experience in the medical device industry, strong communication skills, and a solid understanding of applicable standards.