Description

Primary Duties:

1. Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System.
2. Data Collection and Analysis: Gather post-market data from various sources including customer complaints, adverse even reports, product recalls, industry databases (e.g. MAUDE, EUDAMED), scientific literature review, etc. Analyze trends in product performance and safety to identify potential risks and safety concerns. Work
3.  with cross-functional teams to investigate issues and assess product performance. Regulatory Reporting and Compliance: Prepare detailed post-market surveillance reports including, but not limited to the Post-Market Performance Follow-Up Report (PMPFR), Periodic Safety Update Report (PSUR), and Post-Market Surveillance Report (PMSR). Ensure compliance of post-market surveillance reports for regulatory authorities (e. g. FDA, EU MDR, IVDR and other global agencies).
4. Communication and Process Improvement: Communicate post-market surveillance findings and recommendations to Quality teams and other stakeholders. Collaborate with cross-functional teams to identify opportunities for process improvements and corrective actions.
5. Risk Management: Identify potential risks based on post-market data and collaborate on risk assessments. Track the effectiveness of risk mitigations and report findings to internal stakeholders.
6. Compliance and Audit Preparation: Ensure all data analysis and reporting activities comply with industry standards and post-market regulatory requirements, including EU IVDR (2017/746), FDA 21 CRF Part 803 (MDR), and ISO 13485:2016. Support audits and inspections by providing accurate post-market surveillance documentation.
7. Provide administrative support and help with organizing, attending, and participating with functional group meetings.
8. Assist in the development and improvement of current post-market processes and work with management to identify problem areas and implement solutions.
9. Perform other duties as assigned.

Training and Education:

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).