Affiliate Lead Auditor Medical Device under FDA/EUMDR - South Korea

Affiliate Lead Auditor Medical Device under FDA/EUMDR - South Korea

Position Description

The Affiliate Lead Auditor Medical Device role is responsible for planning and delivering Life Science audit and consulting engagements related to quality/regulatory affairs infrastructure appropriate to the level of risk in a target product. The role is primarily that of an individual contributor, although teamwork is expected. You will be passionate about great client outcomes: working with a team that achieves superior client results because of our highly skilled, specialized, commercially minded Quality System and Regulatory Affairs focus. We are looking for individuals who possess the level of skills, attributes, and talents commensurate with our brand.

Person Description

• Confident personality and competent in getting ideas across to others effectively
• Experience of at least five years working in South Korea as a medical device lead auditor
• Demonstrates ability to work in a team environment, especially when operating remotely
• Passion for patient safety through effective regulatory and quality activities
• Respects the contribution of all colleagues and facilitates consensus on tough issues
• Demonstrates flexibility in day-to-day working in the team and approach to unique client issues
• Established for at least two years as an independent contractor
• Commercial-minded approach seeking to expand business where it makes sense for the client

Basic Qualifications

• Bachelors degree in Engineering, Science, or life science related field
• Evidence of progressively taking more responsibility and leading activities in their field
• A recognized certification as a Lead Auditor for ISO13485; 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
• Fluent in English and Japanese

Industry Requirements

• Experience of at least eight years with 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 21CFR Part 820 and/or relevant EU Regulations
• Experience with any of ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus

Travel

Ability to travel extensively domestically within South Korea. Occasional international travel may be required.