What are the responsibilities and job description for the Postmarket Surveillance Specialist III (Day) position at bioMerieux SA?
Description
Primary Duties:
- Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System.
- 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
- 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).
- 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.
- 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.
- 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.
- Provide administrative support and help with organizing, attending, and participating with functional group meetings.
- Assist in the development and improvement of current post-market processes and work with management to identify problem areas and implement solutions.
- Perform other duties as assigned.
Training and Education:
Master Degree in related field, B.S./B.A. in related field 2 years relevant experience, A.S. 8 years relevant experience.
Possible fields of knowledge: Biology, Biochemistry, Immunology, Microbiology, Chemistry, Biomedical Engineering, Medical Lab Science, Biotechnology.
Experience:
- Minimum 2 years experience in a related field in addition to education requirement
Knowledge, Skills, Abilities:
Technical Skills: Skilled in Microsoft Office applications. Experience with molecular or microbiological diagnostic test or clinical lab experience is preferable.
Analytical Skills: Strong analytical and problem-solving skills with attention to detail. High level of accuracy and attention to detail in analysis, reporting and characterizing data.
Technical Writing: Ability to simplify complex information, with attention to detail, and proficiency in grammar and style.
Scientific Literacy: Ability to read and understand scientific literature, identifying key points, and summarizing findings.
Teamwork: Ability to cultivate trust, participate, and communicate effectively in a team-oriented environment. Ability to work in cross-functional teams.
Autonomy: Ability to work autonomously, making decisions independently while proactively leveraging resources to drive goal completion. Ability to successfully manage workload.
Agility: Ability to adapt to changing priorities swiftly, while taking informed risks and learning from setbacks.
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