Affiliate - Medical / In Vitro Device Lead Auditor

Location: Remote - USA, Canada, UK, Ireland

Hiring Company: Oriel STAT A MATRIX (Website)

Founded in 1968, Oriel STAT A MATRIX is now a business unit of ELIQUENT Life Sciences, a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. 

We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Director consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting, and training services in the medical/in-vitro device market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.

Our Affiliate Medical / In Vitro Device Lead Auditor roles are for independent consultants. They are home-based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology. We therefore seek highly organized individuals who are self-starters, good communicators, and are open to flexible work arrangements, seeking variety in the work they do.

Position Description

The Affiliate Medical / In Vitro Device Lead Auditor 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. Directors with training skills may also have the opportunity to be involved in seminars and course delivery related to quality and regulatory affairs topics. The role is primarily that of an individual contributor, although teamwork is expected.

Person Description

• Confident personality and competent in getting ideas across to others effectively
• 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 in approach to unique client issues
• Established for at least two years as an independent contractor

Basic Qualifications

• Bachelors degree in Engineering, Science, or life sciences related field
• Evidence of progressively taking more responsibility and leading activities in their field
• Leading a substantial number of audits under ISO13485:2016, MDSAP or the EU-MDR with the relevant certification
• Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP

Industry Requirements

• Experience with medical device or in vitro device manufacturing
• Experience with quality systems planning and implementation
• Notified body experience 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 (50% - 75%). Occasional international travel may be required.