Global Post Market Surveillance Expert
Il y a 2 mois
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 45 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.
The Global Post Market Surveillance Expert reports operationally to the Director, Global Quality, Product Development and Lifecycle Management.
The role supports the Global Pre-Market Quality organization to ensure adherence to Quality System regulatory requirements and applicable standards.
Ensure that Quality System processes, specifically around Post Market Surveillance are established, implemented and maintained, and are in adherence with applicable regulations and standards.
Your missions:
- Schedule, Plan, Coordinate and consolidate Post Market Surveillance Reports and Product Safety Update Reports. Analyse obtained data to ensure conclusion are relevant and can be additional information to feed development or follow up processes. Discuss output with relevant stakeholders.
- Ensure follow-up on actions taken as a result of the report(s) analysis.
- Establish and maintain relationships with external and internal stakeholders to ensure that requirements are understood and are being achieved.
- Support the sites when preparing for internal/external inspections.
- Partner with stakeholders to establish and provide quality system training requirements for the function to ensure compliance to appropriate regulations and standards, and adherence to internal procedures.
- Work with the functional head and stakeholders to establish and align annual objectives.
- Define and manage KPIs used to measure performance related to global Post Market Surveillance processes.
You have:
- Graduated of a BAC +3 training in the field of Quality or Biology/scientific field
- Experience in post market surveillance in the major health sector (MD/IVD/Pharmaceutical) would be appreciated
- Knowledge of standards (at least ISO 9001 and ISO 13485)
- Knowledge of regulations (MDSAP, IVDR)
- Ability to collaborate cross-functionally with many multidisciplinary and multicultural teams
- Ability to analyze data, extract conclusions and then ideas for multidisciplinary actions
- Curiosity, ability to challenge the existing
- Rigor and organization
- Fluent/professional level of English both written and spoken
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 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.
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