About this role
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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.