Title: In Vitro Diagnostics (Molecular) RA/QA Consultant - Software
To apply, email resume and cover letter to hr.tech@orielstat.com. Please put “AIVS” in the subject line.
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 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 affiliate consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting, and training services in the market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.
Our roles require the ability to both travel to client sites for delivery and complete assignments at home. We therefore seek highly organized individuals who are self-starters, good communicators, and open to flexible work arrangements, seeking variety in the work they do.
Position Description
The In Vitro Diagnostics RA/QA Consultant – Software Validation is responsible for delivering Life Science consulting engagements related to regulatory affairs infrastructure, appropriate to the level of risk in a target product.
This role is for an independent contractor, for individual or team working involved with other consultants or full-time team members. Applicants must have practical knowledge of molecular in vitro diagnostics and software regulatory activities AND a minimum of 8 years of recent molecular diagnostics device industry experience, including software (algorithms, instrumentation software, etc).
Position Responsibilities
In this role, results will be achieved by:
- Maintaining up-to-date knowledge of areas of specialty, consulting skills, general knowledge of the industry, and awareness of potential or planned changes within the industry
- Delivering consulting engagements with clients in the following areas
- Device research and development
- Clinical trials and performance evaluation (clinical performance, analytical performance)
- Quality management system (ISO 13485:2016) development
- Software development life cycle and software validation
- Risk management
- Post market surveillance
- Device research and development
- Clinical trials and performance evaluation (clinical performance, analytical performance)
- Quality management system (ISO 13485:2016) development
- Software development life cycle and software validation
- Risk management
- Post market surveillance
Travel Candidates must be able to travel domestically at least 50% of the time.
Does this sound like you? If so, we welcome your application.
To apply, email your resume and a cover letter to hr.tech@orielstat.com. Please place Job Code: “AIVS” in the subject line.
Find additional jobs at Oriel STAT A MATRIX.
Oriel STAT A MATRIX is an Equal Opportunity Employer.
