Medical Device Lead Auditor for Quality and Regulatory Affairs
3 weeks ago
Vision Achievement seeks a seasoned Medical Device Lead Auditor to spearhead our quality and regulatory affairs initiatives in China. This exciting opportunity offers the chance to work with a renowned company, utilizing your expertise to ensure compliance with FDA/EUMDR regulations.
Job Description:
The successful candidate will be responsible for planning and delivering audits and consulting engagements related to quality and regulatory affairs infrastructure. This role requires a strong understanding of medical device regulations, including ISO 13485 and MDSAP.
Required Skills and Qualifications:
- Bachelor's degree in Engineering, Science, or life science-related field
- Evidence of progressively taking on more responsibility and leading activities in their field
- Recognized certification as a Lead Auditor for ISO 13485; MDSAP or equivalent
- Demonstrated experience leading a substantial number of audits under FDA regulations (EU-MDR a plus)
- Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP
Industry Requirements:
- At least eight years' experience in medical device or in vitro device manufacturing
- Experience with quality systems planning and implementation under a recognized life science standard
- Experience working with a Notified Body is a plus
- Experience with design control and process validation program development and implementation
- Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21 CFR Part 820 and/or relevant EU Regulations
- Experience with any of ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus
Travel:
The ability to travel extensively within China is required, with occasional international travel possible.
Salary: We offer a competitive salary of $120,000 - $180,000 per year, commensurate with experience, to lead this critical role in our organization.
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Shenzhen, Guangdong, China Vision Achievement Full timeJob DescriptionVision 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...
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