What are the responsibilities and job description for the Postmarket Surveillance Specialist III (Day) position at bioMérieux?
Description
Primary Duties:
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
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.
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 [email protected].
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 [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
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.
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
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.
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 [email protected].
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 [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
