UPCOMING: Regulatory Affairs Specialist

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

This role will play a critical part in supporting global regulatory strategies and ensuring compliance, particularly within the FDA and EU MDR frameworks. The successful candidate will work cross-functionally with R&D, Quality, Clinical, and Manufacturing teams to support product development, submissions, and lifecycle management activities.

Key Responsibilities

• Support preparation, submission, and maintenance of regulatory filings, including 510(k), PMA, Technical Documentation, and Design Dossiers.

• Ensure compliance with EU MDR requirements, including technical documentation, clinical evaluation reports (CERs), and PMS plans/reports.

• Manage post-market activities such as vigilance reporting, PMS data collection, and risk/benefit evaluations.

• Provide regulatory guidance throughout the product lifecycle, from development to commercialization and post-market.

• Monitor and interpret evolving global regulatory requirements, particularly in the US and EU, and assess their impact on company operations.

• Participate in interactions with regulatory authorities and notified bodies, including supporting audits and inspections.

• Collaborate with cross-functional teams to ensure regulatory considerations are integrated into product development, labelling, and quality processes.

• Maintain accurate and current regulatory documentation, databases, and records.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master’s preferred).

• Minimum 3–5 years of regulatory affairs experience in the medical device industry, preferably with Class 2a/b devices.

• Hands-on experience with FDA submissions (510(k), PMA, IDE) and EU MDR technical documentation.

• Strong understanding of ISO 13485, ISO 14971.

• Demonstrated knowledge of post-market surveillance (PMS), vigilance, and clinical evaluation reporting.

• Excellent communication, organization, and problem-solving skills.

• Ability to work effectively in cross-functional and global teams