Regulatory Affairs Manager (UK Medical Devices & IVD)

Tellspec Southampton, England, United Kingdom

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Motivated by the potential of technology to improve lives — whether through safer food or better healthcare | Deep Tech Serial Entrepreneur | EIT…

Regulatory Affairs Manager (UK Medical Devices & IVD)

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

About the Role

Preemie Analytics (www.preemiesensor.com) is seeking a highly skilledRegulatory Affairs Managerto lead the development, implementation, and maintenance of ourQuality Management System (QMS)in compliance withUK Medical Device Regulations (UK IVD), ISO 13485, and other applicable standards. This role will serve as the primary regulatory contact for theMHRA, manageUKCA/CE marking submissions, and ensure adherence topost-market surveillance (PMS)requirements.

The ideal candidate will havestrong expertise in UK/EU medical device regulations, hands-on experience withMHRA submissions, and a proven track record inQMS implementationfor IVDs or medical devices.

Responsibilities

1. Regulatory Affairs & Compliance

• Serve as theprimary UK regulatory contact, managing communications with theMHRAand other relevant bodies.
• Prepare, submit, and maintainUK medical device registrations (UKCA), technical documentation, and EU IVDR compliance.
• Ensure compliance withpost-market surveillance (PMS), vigilance reporting, and incident management.
• Monitor evolvingUK MDR/IVDR regulationsand implement necessary updates to maintain compliance.

2. Quality Management System (QMS) Development

• Develop, implement, and maintain arobust QMSaligned withUK MDR, ISO 13485, and ISO 14971 (risk management).
• Conductinternal audits, manageCAPA (Corrective and Preventive Actions), and drive continuous improvement.
• Overseedocument control, including SOPs, work instructions, and quality records.

3. Quality Control & Compliance Oversight

• Manageincoming, in-process, and final product inspectionsto ensure compliance with specifications.
• Leadnon-conformance investigations, root cause analysis (RCA), and risk assessments.
• Supportsupplier quality auditsand vendor management.

4. Cross-Functional Collaboration

• Provideregulatory guidancefor new product development and design changes.
• Supportinternational regulatory strategies(e.g., EU MDR, FDA) as needed.

Qualifications & Requirements

• Bachelor’s or Master’s degreein Engineering, Life Sciences, Regulatory Affairs, or a related field.
• 4+ years of experienceinmedical device/IVD regulatory affairs, with a strong focus onUK MHRA requirements.
• In-depth knowledgeof:
• UK IVD Regulations
• Hands-on experience withMHRA interactions, technical documentation, and regulatory filings.
• Strong QMS implementation, audit, and CAPA managementskills.
• 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.

Project management & cross-functional collaboration.

Why Join Us?

• Opportunity to shape and optimizeregulatory strategiesfor innovative medical solutions to help premature infants.
• Work in adynamic, compliance-driven environmentwith 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

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