Clinical Auditor

Location: 100% Remote, in the USA

Residency: US Citizen/permanent resident required for US.

Status: Independent Contractor Role.

#lifesciences, #consultant, #RAQA

This exciting role is for independent contractors with significant experience in the RA/QA aspects of life sciences industry sub-sectors such as medical device, in vitro diagnostics, lab-developed tests, pharmaceuticals, clinical manufacturing, and cosmetics.

You will likely be an expert in auditing the design, manufacture, and monitoring of RA/QA under 21 CFR 2XX and/or 8XX sections and have wide life sciences experience. We are particularly looking for people with global regulatory coverage - multiple jurisdictions in addition to US, UK, EU.

We seek consultants, auditors and instructors, and those who have expertise and a passion for patient safety and population health improvement. We have good rates of compensation, defined by the project, and a top-rated team to work alongside you.

The roles 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.

You would be responsible for planning and delivering Life Science 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.

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 or consumer safety through effective regulatory and quality activities
• Respect the contribution of all colleagues and facilitate consensus on tough issues
• Demonstrates flexibility in day-to-day working in the team and in approach to unique client issues
• Established as an independent contractor or contract-for-hire

Essential Base Qualifications

• Bachelors degree in Engineering, Science, or and Life Sciences related field
• Evidence of progressively taking more responsibility and leading activities in their field (such as writing regulatory submissions)
• Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.

Essential Industry Requirements

• Experience with auditing design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
• Experience with quality systems planning and implementation, design control and process validation
• Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
• Experience with ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013; ISO 14155  a plus

Travel

Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.