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Regulatory & Compliance Specialist

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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:

  • Responsible for the management of vigilance and field actions as part of Vigilance operational team (VOT) team
  • Direct responsibility for review and approval of Incident reporting decisions WW on the products in the scope of the corresponding VOT team (microbiology OR immunoassay/molecular biology)
  • Responsible for the management of the Field action board process for all products in the scope of the corresponding VOT team (microbiology OR immunoassay/molecular biology)
  • Key contact for competent authorities on vigilance and field action activities. Be the responsible party for communication with FDA on FSCAs, MDRs, terminations and all follow-up.
  • Main contributor in crisis management.

 

Responsibilities:

  • Perform Weekly PRE no review: complaint assessment & decision. Complaint assessment taking into account the risk to patient in compliance with the Vigilance requirement (EU and FDA regulation, MEDDEV guidelines, French Public Health Code). Make a decision of incident reportability to CA. Complete the associated vigilance reports (eMDR, MIRs)
  • Complete  the assessments of complaints and reports to Competent Authorities (GA, LA, eMDR, Final / FU MIR , Supplemental eMDR) completed by the Vigilance specialists.
  • Manage low complexity transversal meetings (Field Action Board) to make a decision on product issues confirmed on the field and define the actions requested in the field if necessary. Complete the associated documentation. Manage FSCA closure  / Questions from CA related to FSCAs with the experts.
  • Contribute to the completion of Post Market Surveillance (PMS) reports in assigned region : analyze PMS data  & QSMR data (if needed)
  • Manage information and communication with Regulatory Authorities; interact with regulatory authorities on a regular basis
  • Contribute to the fact that decisions and communications are in compliance with internal procedures and directives, and train.
  • Assist in preparing audits/inspections (MDSAP, Corporate Vigilance audits and potential CA inspections), participate as needed.
  • Contribute to newcomers trainings
  • Perform RACM reviews as needed (US only)

 

Studies and Experience:

  • Knowledge of compliance requirements, guidance documents and processes (local/regional) with 1-3 years of practice in the field of IVD/MD in an international environment.
  • 1-2 years experience in quality postmarket vigilance.
  • Knowledge of Vigilance Guidance Documents, FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR820,ISO 13485, ISO 9001).
  • Familiar with local regulatory agency organization, with company product profiles and technology

 

Skills and Qualifications:

  • Good knowledge in IVD products a plus.
  • Methodic and pragmatic; provide directions for proper implementation. 
  • Leadership: Routine problem solving, develop rationale and justify position, interpersonal skills
  • Communication skills: work in an international environment and lead cross functional meetings
  • Reliable attendance and punctuality is an essential job function required for this position.

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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