Medical Device Lead Auditor with Regulatory Expertise

4 weeks ago


Shenzhen, Guangdong, China Vision Achievement Full time
Job Description

Vision Achievement seeks a seasoned Medical Device Lead Auditor to lead Life Science audits and consulting engagements in China. This role requires a strong background in quality/regulatory affairs infrastructure, with a focus on FDA/EUMDR compliance.

About the Role

This is an individual contributor position that involves planning and delivering audit and consulting engagements. You will work closely with a team to achieve superior client results and ensure great outcomes for our clients.

Key Responsibilities
  • Lead Life Science audits and consulting engagements related to quality/regulatory affairs infrastructure
  • Develop and implement effective quality systems and regulatory strategies
  • Maintain expertise in FDA/EUMDR regulations and industry standards
Requirements
  • Bachelor's degree in Engineering, Science, or life science-related field
  • At least 8 years of experience in medical device or in vitro device manufacturing
  • Experience with quality systems planning and implementation under recognized life science standards
  • Demonstrated expertise in interpreting and applying codes, regulations, and standards in the medical device industry
Benefits

This role offers a competitive salary and benefits package, including:

  • A salary range of $120,000 - $180,000 per year, depending on experience
  • Opportunities for professional growth and development
  • A dynamic and collaborative work environment
Travel Requirements

Ability to travel extensively domestically within China, with occasional international travel required.



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