Medical Device Lead Auditor with Regulatory Expertise
4 weeks ago
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 RoleThis 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
- 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
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
Ability to travel extensively domestically within China, with occasional international travel required.
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