Affiliate Consultant / Trainer Clia/Ldt

Location:
100% Remote, in the USA
Residency:
US Citizen/permanent resident required for US.
Client:
Oriel STAT A MATRIX ()
This exciting role is for independent contractors or employee contractors with significant experience in the RA/QA aspects of lab developed tests and Clinical Laboratory Improvement Amendments (CLIA). You will likely be an expert in manufacturing devices or regulatory affairs under FDA, and have wide life sciencesexperience.
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 project and a top-rated team to work alongside.
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 training, audit or 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 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 as an independent contractor or contract-for-hire
Essential Base Qualifications
Bachelors degree in Engineering, Science, or life sciences related field
Evidence of progressively taking more responsibility and leading activities in their field
Significant experience in RA/QA matters related to CLIA and lab developed tests (LDT)
Essential Industry Requirements
Experience with in-vitro device 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 any of ISO 17025:
2017;
ISO 14971:
2019;
ISO 27001:
2013 a plus
Travel
Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.