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Regulatory Affairs Manager (UK Medical Devices & IVD)

Location: United Kingdom (Remote/Hybrid options if applicable)

Department: Preemie Analytics – Medical Division

About the Role

Preemie Analytics (www.preemiesensor.com) is seeking a highly skilled Regulatory Affairs Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) in compliance with UK Medical Device Regulations (UK IVD), ISO 13485, and other applicable standards. This role will serve as the primary regulatory contact for the MHRA, manage UKCA/CE marking submissions, and ensure adherence to post-market surveillance (PMS) requirements.

The ideal candidate will have strong expertise in UK/EU medical device regulations, hands-on experience with MHRA submissions, and a proven track record in QMS implementation for IVDs or medical devices.

Responsibilities

1. Regulatory Affairs & Compliance

• Serve as the primary UK regulatory contact, managing communications with the MHRA and other relevant bodies.
• Prepare, submit, and maintain UK medical device registrations (UKCA), technical documentation, and EU IVDR compliance.
• Ensure compliance with post-market surveillance (PMS), vigilance reporting, and incident management.
• Monitor evolving UK MDR/IVDR regulations and implement necessary updates to maintain compliance.

2. Quality Management System (QMS) Development

• Develop, implement, and maintain a robust QMS aligned with UK MDR, ISO 13485, and ISO 14971 (risk management).
• Conduct internal audits, manage CAPA (Corrective and Preventive Actions), and drive continuous improvement.
• Oversee document control, including SOPs, work instructions, and quality records.

3. Quality Control & Compliance Oversight

• Manage incoming, in-process, and final product inspections to ensure compliance with specifications.
• Lead non-conformance investigations, root cause analysis (RCA), and risk assessments.
• Support supplier quality audits and vendor management.

4. Cross-Functional Collaboration

• Provide regulatory guidance for new product development and design changes.
• Support international regulatory strategies (e.g., EU MDR, FDA) as needed.

Qualifications & Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
• 4+ years of experience in medical device/IVD regulatory affairs, with a strong focus on UK MHRA requirements.
• In-depth knowledge of:
• UK IVD Regulations
• ISO 13485 (QMS) & ISO 14971 (Risk Management)
• UKCA/CE marking submissions & post-market surveillance
• Hands-on experience with MHRA interactions, technical documentation, and regulatory filings.
• Strong QMS implementation, audit, and CAPA management skills.
• Excellent communication skills (written & verbal), with the ability to liaise with regulatory authorities.
• Regulatory Affairs Certification (RAC) is a plus.

Qualifications

✔ Must be a UK resident (applications from non-residents will not be considered).

✔ Fluent English (written & spoken) – 100%+ proficiency required.

✔ Regulatory expertise (UK MHRA/EU IVDR) – 4+ years minimum.

✔ Strong quality management & compliance mindset.

✔ Analytical thinking & attention to detail.

✔ Problem-solving & risk assessment skills.

✔ Project management & cross-functional collaboration.

Why Join Us?

• Opportunity to shape and optimize regulatory strategies for innovative medical solutions to help premature infants.
• Work in a dynamic, compliance-driven environment with a growing team.
• Competitive compensation and professional growth opportunities.

🔍 Ready to apply? Submit your CV, proof of residence, and cover letter detailing your regulatory experience with UK MHRA & QMS.