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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.
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.
BSI is a multinational organization that provides training, certification, and ISO management systems solutions to businesses globally. The company operates across multiple service lines including payroll and HR software, financial and accounting software, and training solutions focused on ISO standards and compliance. BSI serves clients ranging from small to midsize organizations to enterprise-level customers across the Americas and internationally. The company is mission-driven, stating that it exists to create positive change for people and the planet.
