GQA Technical and Regulatory Reviewer
# GQA Technical and Regulatory Reviewer **BSI** · China · `Remote` · `Full Time` 💼 **Уровень роли:** `Mid-level` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Regulatory-Affairs]` `[Quality-Assurance]` `[Medical-Device-Certification]` `[Technical-Reviewer]` `[Quality-Management]` `[Regulatory-Reviewer]` `[Auditor]` `[Technical-Review-Engineer]` `[Regulatory-Quality-Auditor]` `[QA-Reviewer]` `[Technical-Review-Specialist]` `[Quality-Assurance-Reviewer]` `[Quality-Review-Analyst]` `[Quality-Systems-Reviewer]` `[Technical-QA-Specialist]` --- ### About the Role We exist to create positive change for people and the planet. Join us and make a difference too! 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. Originally posted on Himalayas
- Regulatory-Affairs
- Quality-Assurance
- Medical-Device-Certification
- Technical-Reviewer
- Quality-Management
- Regulatory-Reviewer
- Auditor
- Technical-Review-Engineer
- Regulatory-Quality-Auditor
- QA-Reviewer
- Technical-Review-Specialist
- Quality-Assurance-Reviewer
- Quality-Review-Analyst
- Quality-Systems-Reviewer
- Technical-QA-Specialist
Наблюдалась 2026-10-01, впервые 2026-10-01, источник — Himalayas (JSON API).