Medical Device Technical/Regulatory Reviewer(home based)

The British Standards Institution

Job Overview

Location

5 Locations

Job Type

Full-time

Full Job Description

📋 Description

• The Medical Device Technical/Regulatory Reviewer role at BSI is critical to ensuring the integrity and global consistency of medical device certification processes, directly supporting patient safety and regulatory compliance across international markets.
• Day to day, the reviewer will provide technical support for ISO 13485 and CE certification schemes, including investigating customer appeals, reviewing audit reports, delivering certification decisions, conducting competence verification for auditors, and advising QMS auditors and internal teams on medical device quality management system requirements.
• The role sits within BSI’s Regulatory Services Global Quality & Accreditation team, a globally distributed group responsible for upholding the highest standards in medical device certification under ISO 17021, MDSAP, MDR/IVDR, and other regulatory frameworks, serving over 86,000 clients across 193 countries.
• In this role, the individual will deepen their expertise in medical device QMS standards, gain experience in global regulatory schemes, develop leadership in technical decision-making, and contribute to continuous improvement projects that enhance audit consistency and organizational excellence.

🎯 Requirements

• Previous experience coordinating or conducting audits of medical device manufacturers to ISO 13485
• Minimum of two years of hands-on manufacturing experience and two years of quality management experience
• First or second degree in engineering, science, or a related discipline
• Good understanding of QMS requirements for medical devices, including ISO 13485, MDD, AIMD, IVDD, MDR/IVDR, and MDSAP
• Good understanding of product and QMS certification concepts and principles
• Comprehensive understanding of quality systems, philosophies, and principles

🏖️ Benefits

• Competitive total reward package
• Independent and varied job in an international environment
• Flexible working hours
• Ongoing training and development
• Opportunity to work home-based with optional global travel for training, conferences, and meetings
• Commitment to diversity, inclusion, and belonging as an Equal Opportunity Employer

Skills & Technologies

Remote

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The British Standards Institution

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About The British Standards Institution

Founded in 1901, The British Standards Institution (BSI) is the United Kingdom's national standards body. It develops and publishes technical standards and certification services across quality, safety, risk, and sustainability. BSI offers testing, inspection, training, and supply-chain compliance solutions to help organizations meet regulatory and industry requirements worldwide.

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