Job Description:

Founded in 1968, Oriel STAT A MATRIX is a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We achieve superior client results by selecting highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Affiliate consultants with exceptional skills in specific areas. Together, our team executes best-in-class advisory, audit, consulting, and training services in the medical/in vitro device market.

Position: Medical Device Lead Auditor Affiliate

Position Description:

The Medical 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. Affiliates 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, with gravitas, and competent in getting ideas across to others effectively

- Demonstrated ability to work in a team environment, especially when operating remotely

- Passion for patient safety through effective regulatory and quality activities

- Respect for 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 willing to be an employee-contractor

Basic Qualifications:

- Bachelor’s degree in Engineering, Science, or life sciences related field

- Evidence of progressively taking more responsibility and leading activities in their field

- Leading substantial audits under ISO13485:2016; MDSAP; 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 QMS: quality systems planning and implementation

- 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 Directives

- Experience with any of ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus

Travel:

Ability to travel extensively (25% - 50%) to client sites.

Our Affiliate Program:

Over the past 60 years, we’ve developed an Affiliate Relationship Model that includes maintaining a robust inventory of your skills and experiences, allows for open and constructive communication, and supports the creation of personal development plans. This model helps us understand the type of work you want to do, determine how we can complement your existing business, and ensure that we do everything necessary to ensure a successful client engagement for all of your assignments. Through this approach, we develop mutually successful, long-term relationships. Many of our Affiliates have worked alongside us for over 20 years.

An ideal candidate should have:

- A minimum of 8 years of real-world, practical medical device RA/QA experience

- Demonstrable success and career progression

- An understanding of industry trends and current/proposed regulations

- A business-centric, practical approach to RA/QA

- Effective communication skills both spoken and written

- A desire for mutual success

What Kind of Commitment Is Required from Our Affiliate Consultants?

Candidates should:

- Be looking to work between 60 and 120 days per year alongside us

- Be free to travel to client sites

- Have independent consulting experience (internal consulting experience may work too)

- Be seeking affiliation with a firm that has high expectations of itself and its Consultant team

How Do We Work Together?

Our internal team is focused on selling and marketing our services. For a new business engagement, prospective Affiliates are identified based on a matching system that evaluates the scope of work relative to your skills, preferences, location, and availability. Once identified as a prospective resource for an assignment, you can confirm or decline the engagement. If you accept the engagement, you will receive detailed terms for the assignment. We will also provide you with technical and business development support, tools, and templates to ensure mutual success. During the engagement, an established protocol is in place to ensure project progression and address opportunities to expand the Scope of Work. Should the project expand and assuming your skills meet the expanded scope, your work will be extended on the project. About 50% of our projects expand to include additional work.

How Does One Get Compensated?

Compensation rates are tied to the service type and your role on an assignment. Rates are defined in our Affiliate Agreement, which you will sign before engaging with us. We always align the Affiliate compensation with the model in which we are being paid, whether it is by the hour, by the day, or by the project. This ensures that Oriel STAT A MATRIX and our Affiliate are aligned in goals and expectations at all times.

Salary Package: $750.00 (US Dollar) per day