GQA Technical and Regulatory Reviewer

BSI; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Maternity leave

Nursing leave

Paternity leave

Bereavement leave

Learning and development

Job summary

BSI is seeking a GQA Technical and Regulatory Reviewer to own quality management system processes for medical devices. The role supports ISO 13485 and product certification, in China and globally, with occasional travel for audits and regulator interactions.

Successful candidates will have a degree in Engineering or Science, strong QMS knowledge, CNCA/CCAA familiarity, and fluent English/Chinese communication. This is a home-based position with international responsibilities.

Qualifications

• Strong understanding of QMS requirements in China and global standards (ISO 13485, 17021, 17065).
• Experience with ISO/IEC audits and medical device product certification processes.
• Excellent written and verbal communication in English and Chinese.

Responsibilities

• Support rollout of regulatory service policies and QMS audits globally.
• Contribute to ISO 13485 and product certification inspections and regulator audits.
• Deliver certification decisions for ISO 13485 and product schemes where possible.
• Maintain qualifications for China certification schemes and CNCA/CCAA rules.
• Assist in auditor qualification and competence development programs.

Skills

QMS knowledge

ISO 13485 understanding

Auditing

Communication skills

Bilingual English/Chinese

Education

Engineering/Science degree

Tools

CNCA rules

Job description

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, nursingleave, 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.