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Global Quality & Accreditation (GQA) Technical and Regulatory Reviewer
China- homebased, occasional travel required
About the role
Our Regulatory Services GQA team are looking for a GQA Technical and Regulatory Reviewer who will provide quality management system ownership to medical devices/product certification and QMS audit teams both in China and globally.
Responsibilities
- Support the roll out of policy decisions and processes for regulatory servicesQMS audits in China and globally
- Provide support of the ISO 13485 certification / product certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits
- Deliver certification decisions for ISO 13485 certifications and product certification schemes eligible, with a goal to being qualified across all non-CE ISO 13485 schemes and product certification schemes, where resource allows
- Maintain qualifications and registration required for participation in China certification schemes, including compliance with applicable CCAA competency and continuing professional development requirements
- Participating in smaller improvement projects ensuring appropriate adherence to procedures
- Support in hosting regulator or accrediting body audits
- Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices and product certifications
- Competence verifier activities to support the auditor qualification process, if appropriate
To be successful in the role, you will have:
- First or second degree in Engineering, Science, or related discipline
- A good understanding of QMS requirements as applied in China as well as applicable regulations and standards (ISO 13485, 17021, 17065, MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular)
- CCAA qualified auditor within China certification schemes, including application and interpretation of CNCA and CCAA requirements
- Knowledge of China certification scheme governance, auditor qualification and competence requirements, and the application of CNCA certification rules
- Excellent interpersonal and communication skills (written and oral) in Chinese and English
BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 15-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, maternity leave, nursing leave, paternity leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.
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About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
Skills Required
- Understanding of medical device QMS requirements, including ISO 13485, MDD, AIMD, IVDD, MDR, IVDR, and MDSAP
- Experience coordinating or conducting audits of medical device manufacturers to ISO 13485, such as supplier or internal audits
- Ability to confidently explain product and QMS certification concepts and principles
- Degree in engineering, science, or a related discipline
BSI Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BSI and has not been reviewed or approved by BSI.
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Flexible Benefits — Flexible benefits are positioned as part of the MyReward approach, allowing tailoring based on local eligibility and individual needs. Core elements like life assurance, income protection, and EAP access are framed as consistent pillars even as specifics vary by country.
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Leave & Time Off Breadth — Leave offerings are described as generous in certain markets, including annual leave starting around 27 days where that is standard and, in some U.S. postings, about four weeks of PTO plus a set holiday calendar. Additional time-off practices like occasional year-end office closure are also described as part of the overall package in some teams.
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Wellbeing & Lifestyle Benefits — Well-being support is presented as visible at the corporate level, including EAP access and expanded programs such as menopause support and mental-health first aid. Flexible work under “Smart Working” is repeatedly positioned as a work–life balance and inclusion lever that complements the total rewards package.
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What We Do
BSI is your business improvement partner. We have shaped best practice for over 100 years, partnering with organizations to accelerate progress and create impact for a fairer society and sustainable world
