China-based Global GQA Technical & 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

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.