Global Quality and Accreditation: Technical and Regulatory Reviewer

5 months ago


Chaoyang Qu, China BSI Full time

Great that you're thinking about a career with BSI

Role Title: Global Quality & Accreditation: Technical and Regulatory Reviewer

Reporting: Global Quality & Accreditation: Technical Manager

Location: UK/EU/APAC - Homebased

The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally. 

The role comprises of three main elements:

Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring; Supporting in ad hoc improvement projects; Technical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.


Responsibilities & Accountabilities:

Support the roll out of policy decisions and processes for medical device QMS audits globally; Provide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits; Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes, where resource allows; 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; Competence verifier activities to support the auditor qualification process, if appropriate.

Suitable candidates should demonstrate the following:

A good understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular). A good understanding of product and QMS certification concepts and principles A comprehensive understanding of quality systems, philosophies and principles An awareness of certification, accreditation and notified body roles Experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits) Minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.



  • Chaoyang Qu, China BSI Full time

    As a key member of our team at BSI, you will be responsible for providing medical device quality management system ownership to medical device and QMS audit teams globally.The role comprises three main elements:Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification, and competence...


  • Chaoyang Qu, China BSI Full time

    Job Title: Global Quality and Accreditation SpecialistBSI is seeking a highly skilled Global Quality and Accreditation Specialist to join our team. As a key member of our quality management team, you will be responsible for providing technical expertise and support to our medical device and QMS audit teams globally.Key Responsibilities:Develop and maintain...


  • Chaoyang Qu, China BSI Full time

    At BSI, we are seeking a highly skilled Global Quality and Accreditation Specialist to join our team.The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally.The responsibilities include:Developing and maintaining technical expertise in key areas relating to certificate decision making,...


  • Chaoyang Qu, China BSI Full time

    At BSI, we are seeking a highly skilled Technical and Regulatory Reviewer to join our team.Key Role Responsibilities:Develop and maintain technical expertise in key areas related to medical device quality management systems.Support improvement projects and provide technical support for ISO 13485 certification-based schemes globally.Deliver certification...


  • Chaoyang Qu, China BSI Full time

    Great that you're thinking about a career with BSI.Job Title: Global Quality and Accreditation: Technical and Regulatory ReviewerJob Summary: We are looking for a skilled professional to join our team as a Global Quality and Accreditation: Technical and Regulatory Reviewer.Key Responsibilities:Provide quality management system ownership to medical device and...


  • Chaoyang Qu, China BSI Full time

    Job SummaryAs a Global Quality Assurance Specialist at BSI, you will play a key role in providing quality management system ownership to medical device and QMS audit teams globally.Key ResponsibilitiesDevelop and maintain technical expertise in key areas relating to certificate decision making, competence verification, and competence monitoring.Support...


  • Chaoyang Qu, China BSI Full time

    Job Description:As a Medical Device Quality Specialist at BSI, you will play a vital role in ensuring the quality and safety of medical devices globally. Your primary responsibility will be to provide quality management system ownership to medical device and QMS audit teams.Key Responsibilities:Develop and maintain technical expertise in key areas related to...


  • Chaoyang Qu, China BSI Full time

    At BSI, we are seeking a highly skilled Quality Assurance Specialist to join our team.Job DescriptionThis role involves providing medical device quality management system ownership to audit teams globally.The position comprises of three main elements:Developing and maintaining technical expertise in key areas relating to certificate decision making,...


  • Chaoyang Qu, China BSI Full time

    Become part of our team at BSI as a Technical Microbiologist and Quality Assurance Specialist.Job Title: Technical Specialist and Scheme Manager (Microbiology)Location: RemoteWe are seeking a skilled Microbiologist to join our team and help clients navigate the areas of compliance within the areas of sterilization, packaging, and microbiological testing...


  • Chaoyang Qu, China BSI Full time

    We have a career opportunity for a Technical Specialist in Microbiology with BSI. This role involves working with clients to ensure compliance with regulatory requirements, including audits and medical device reviews. The ideal candidate will have a strong background in microbiology and experience with ISO 13485. If you are a motivated professional looking...


  • Chaoyang Qu, China BSI Full time

    Job DescriptionWe are seeking a highly skilled Senior Medical Device Quality Assurance Specialist to join our team. This role will be responsible for providing medical device quality management system ownership to medical device and QMS audit teams globally.About the RoleThis is an exciting opportunity for a talented professional with experience in...


  • Chaoyang Qu, China BSI Full time

    Job Title: Technical Specialist and Scheme Manager (Microbiology)Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for a new challenge?BSI is seeking qualified and experienced industry microbiologists to help clients navigate compliance within areas of sterilization, packaging, and microbiological testing.In this role, you will...

  • Senior Microbiologist

    16 hours ago


    Chaoyang Qu, China BSI Full time

    BSI is a leading provider of standards-based solutions in the fields of health, infrastructure, industry, and performance management.We are seeking a Senior Microbiologist to join our team in China or Japan. This role requires strong technical expertise in microbiology, sterilization, and quality assurance. As a Senior Microbiologist, you will be responsible...


  • Chaoyang Qu, China BSI Full time

    Great that you're thinking about a career with BSI! Job title: Technical Specialist and Scheme Manager (Microbiology) Location : China / Japan (homebased) Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? BSI hires qualified and experienced industry microbiologists to help clients navigate...


  • Chaoyang Qu, China BSI Full time

    Great that you're considering a career with BSIJob Title: Technical Specialist and Scheme Manager (Microbiology)Location: RemoteAre you a Microbiologist, Sterilization Engineer, or Quality Manager looking for a new challenge?BSI is seeking qualified and experienced industry microbiologists to help clients navigate compliance within the areas of...


  • Chaoyang Qu, China BSI Full time

    At BSI, we're seeking a highly skilled Technical Specialist to join our team in China or Japan. As a Microbiologist, Sterilization Engineer, or Quality Manager, you'll have the opportunity to apply your expertise to impact patient safety and help determine which new products go to market.Key Responsibilities:• Conduct comprehensive audits of clients'...


  • Chaoyang Shi, China BeiGene Full time

    BeiGene is seeking a Senior Director, Commercial Product Quality External Supply, who will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality...


  • Chaoyang Shi, China BeiGene Full time

    Growth Opportunities at BeiGene BeiGene, a rapidly expanding pharmaceutical company, offers experienced professionals exciting opportunities for growth and development. When selecting candidates, we look for motivated, collaborative, and results-driven individuals who share our passion for fighting cancer. Job Summary: The Senior Director, Commercial...


  • Chaoyang Shi, China BeiGene Full time

    BeiGene is a global biotechnology company that is committed to developing innovative cancer therapies. We are seeking a highly experienced and motivated Senior Director, Commercial Product Quality External Supply to join our team.Job Summary:The Senior Director, Commercial Product Quality External Supply will be responsible for ensuring the commercial...


  • Chaoyang Qu, China Initiate International Full time

    Exciting Opportunity: Technical Project Manager - China About Our Client: Step into the future of payments with our client, a global leader in innovative payment solutions. Trusted by some of the world’s biggest brands like Amazon, Netflix, Google, and Tencent, our client connects millions of consumers to seamless, secure payment experiences. Operating in...