Regulatory and Quality Compliance Specialist
Location: Salt Lake City, United States
Position Type: Unfixed Term
Job Function: Quality
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
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.
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).
