Title: Medical Device / In Vitro Diagnostic Device RA/QA Consultant - Clinical Writing

To apply, email resume and cover letter to hr.tech@orielstat.com. Please put “AFRA” 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 

In this role, results will be accomplished by:

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:
    • Essential requirements documentation
    • Postmarket surveillance
    • Clinical evaluation reports
    • Risk management
    • Declaration of conformity
    • Assembly of product family technical documentation
Basic Qualifications
  • Bachelor’s degree in engineering, science, or healthcare-related field
  • A minimum of 8 years of recent experience in the medical device / in vitro diagnostic sector
  • Essential experience for our current positions: clinical writing and or regulatory submissions
  • Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP
  • Experience across the life cycle of devices desirable
  • Design control and process validation program development and implementation

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: “AFRA” in the subject line.

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Oriel STAT A MATRIX is an Equal Opportunity Employer.