Title: Medical Device RA/QA EU MDR Management Consultant

To apply, email resume and cover letter to hr.tech@orielstat.com. Please put “MGCC” 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 Medical Device RA/QA EU MDR Management Consultant 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 individual contributor who will engage in a significant amount of teamwork with our full-time staff and/or other affiliate team members. Applicants must have practical knowledge of EU MDR activities and a minimum of 5 years of recent medical device industry experience.

Especially important will be logistics of data mining, skills in determining indications of use/intended use, product classification, and an understanding of both quality assurance and regulatory affairs as they relate to the EU MDR.

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 5 years of recent experience in the medical device sector
  • Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP
  • Product submissions with EU MDR experience
  • EU MD Directive compliance and CE Mark product certifications
  • Design control and process validation program development and implementation
Employment Status
9- to 12-month contract with employee status. 

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: “MGCC” in the subject line.

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Oriel STAT A MATRIX is an Equal Opportunity Employer.