Join our Talent Network
Skip to main content

Regulatory and Quality Compliance Specialist

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Position Summary:

As a Regulatory and Compliance Specialist, you will b responsible for the management of vigilance and field actions as part of Vigilance operational team (VOT) team. Direct responsibility for the assessment of reportability to competent authorities and  completion of associated reports European & FDA on the products in the scope of the corresponding Vigilance Team. You will conduct filed action board meetings, complete associated documents ( filed actions) and report to competent authorities under the approval of the experts or managers.

 

Primary Duties:

  • Perform the assessment of  Potential Reportable Event.
  • Complete assessments.
  • Make decisions related to incident reportability to competent authorities taking into account the risk to patient in compliance with the application regulation (European & FDA).
  • Complete the associated vigilance reports  to competent authorities (MDR, supplemental EMDR, Initial Final  MIRs , Annex VII trend reports)
  • Manage transversal meetings (Field Action Board) to make decisionson product issues and contribute to decision making regarding the action requested on the field. 
  • Contribute to the completion of Post Market Surveillance activities ( PMS data, QMS data, trend reports).
  • Assist in preparing internal and external audits/inspections (MDSAP, Corporate Vigilance audits and potential CA inspections), as needed 
  • Contribute to the interface with competent authorities on vigilance and field action activities to assist the VOT Experts and Managers (answer to CA questions)

 

Education and Experience:

  • 1+ years of experience in the field of IVD/MD in an international environment
  • Knowledge of compliance requirements, guidance documents and processes (local/regional)

    Knowledge of Vigilance Guidance Documents, FDA 806 & 803 or / and European IVDR Regulation , QMS requirements (QSR820,ISO 13485, ISO 9001).

    Familiar in interaction with  local regulatory agency organization

 

Knowledge, Skills and Abilities:

  • Methodic and pragmatic; provide directions for proper implementation. 

    Communication skills : work in an international environment and lead cross functional meetings, interpersonal skills

    Reliable attendance and punctuality is an essential job function required for this position.

 

 

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

Share: share to e-mail

Similar Jobs

QC Analyst 1

Durham, United States
Quality

QC Support Analyst 2 - 1st Shift

Durham, United States
Quality

Staff Validation Engineer, QC

Durham, United States
Quality

Associate Manager, Document Control - Durham

Durham, United States
Quality

Manager, Quality Floor Support - 3rd shift

Durham, United States
Quality

Global Product Risk Management Expert

Durham, United States
Quality

Regulatory and Quality Compliance Specialist

Durham, United States
Quality

QC Analyst 1 Biochem - 2nd Shift

Durham, United States
Quality

Sr Specialist Quality & Regulatory Compliance

Durham, United States
Quality