[Hiring] Global Quality & Accreditation Technical and Regulatory Reviewer @BSI

Role Description

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 services QMS audits in China and globally.
• Provide support of the ISO 13485 certification / product certification and CE schemes, including investigating customer appeals, report reviewing, and supporting activities during regulator audits.
• Deliver certification decisions for ISO 13485 certifications and product certification schemes, 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.
• Participate 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.
• Conduct competence verifier activities to support the auditor qualification process, if appropriate.

Qualifications

• 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.

Benefits

• Competitive total reward package.
• Independent and varied job in an international environment.
• Flexible working hours.
• Ongoing training and development.
• 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.
• A wide range of flexible benefits that can be tailored to suit your lifestyle.

Company Description

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.

• Partners with more than 77,500 clients in 195 countries.
• Engages with a 15,000 strong global community of experts, industry and consumer groups, organizations, and governments.
• Utilizes extensive expertise in key industry sectors including automotive, aerospace, built environment, food and retail, and healthcare.
• Helps clients fulfill their purposes while tackling society’s critical issues.
• Dedicated to fostering a diverse and inclusive workplace.