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.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
As a Regulatory and Compliance Specialist, you will b responsible for the management of vigilance and field actions as part of Vigilance operational 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.
What will be your responsibilities at bioMérieux?
- You have to perform and manager Weekly PRE no review: complaint assessment & decision.
- You have to 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),
- You have to make a decision of incident reportability to CA. Complete the associated vigilance reports (eMDR, MIRs),
- You have to complete the assessments of complaints and reports to Competent Authorities (GA, LA, eMDR, Final / FU MIR , Supplemental eMDR) completed by the Vigilance specialists.
- You have to 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 and complete the associated documentation.
- You have to manage FSCA closure / Questions from CA related to FSCAs with the experts and contribute to the completion of Post Market Surveillance (PMS) reports in assigned region (Analyze PMS data & QSMR data),
- You have to manage information and communication with Regulatory Authorities, to interact with regulatory authorities on a regular basis and contribute to the fact that decisions and communications are in compliance with internal procedures and directives, and train,
- You have to assist in preparing audits/inspections (MDSAP, Corporate Vigilance audits and potential CA inspections),
- Contribute to newcomers trainings Perform RACM reviews as needed (US only).
Who are you ?
- You have more than 3 years’ experience of practice in the field of Medical Devices in an international environment,
- You have more than 3 – 7 years’ experience of practice in the field of In-vitro Diagnostic industry, in an international environment,
- You have a strong knowledge of compliance requirements, guidance documents and processes (local/regional),
- You have a significant knowledge of Vigilance Guidance Documents, FDA 806 & 803 or / and European IVDR Regulation , QMS requirements (QSR820,ISO 13485, ISO 9001),
- You are familiar in interaction with local regulatory agency organization,
- You are methodic and pragmatic,
- You have the ability to provide directions for proper implementation,
- You have a strong leadership, an ability to manage and solve some routine problem and in the same time to develop rationale and justify position,
- You have a relevant communication skills,
- You have already worked in an international environment and leaded cross functional meetings,
- Reliable attendance and punctuality is an essential job function required for this position,
- Fluent in english and french.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.