Vigilance Specialist - CRAPONNE, France - bioMerieux SA Career Site - MULTI-LINGUAL

Description

bioMérieux S.A.

Vigilance Specialist - All Genders

As a Vigilance Specialist, you will be 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 (field corrective actions) and report to competent authorities under the approval of the manager.

What will be your responsibilities ?

• 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 a strong knowledge of compliance requirements, guidance documents and processes (local/regional),
• You have a significant knowledge of Vigilance Guidance Documents, FDA Part 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,
• Fluent in english and french.

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our employees to blossom throughout their career, while respecting each employee's individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

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