Especialista en vigilancia post

This position will encompass a hybrid role: Supports both PSUR and PMPF processes. As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts by generating initial post market surveillance (PMS) reports and Post Market Performance Follow Up (PMPF) reports (U.S.) for IVDR class A and B products. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data. QE will work with subject matter experts to analyze product related data and document conclusions of the review activities. In addition, in this role the candidate will be responsible for ensuring Post Market Performance Follow up deliverables are completed in a timely manner (e.g. scientific literature review, post market clinical studies, marketing evaluations, clinical and published experience gained, as well as assessment of product benefit risk and overall report conclusion). How the Candidate Will Make an Impact Analysis of post market data and reviewing completed reports with business partners. Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance. Execute PMPF process and assure tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow up reports. Strong research, writing and communication skills, as well as a solid understanding of scientific concepts. Review and analyze scientific literature and summarize findings in applicable protocol reports. Maintain, archive and completed controlled quality records. Coordinate PMS deliverables with internal business partners. Facilitate and/or chair local/regional PMS Board meetings. Support various QMS and PMS projects (local and global) as needed. Support internal/external audits as needed. Perform other related duties and assignments as needed. What the Candidate Brings Bachelor’s degree or equivalent in a related life science/technical/engineering discipline and 5+ years experience in a regulated manufacturing industry or equivalent combination of education. Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad. Understanding of product post market surveillance requirements for IVD products a plus. Working knowledge of device/drug/biotech manufacturing processes. Detail-oriented and ability to multitask. Problem solving, decision making, time management, organization, communication, leadership, and computer skills. Advanced technical writing and word processing skills. Experience with electronic QMS systems (i.e. Veeva) a plus Compensation: Market compatible compensation. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. people with special abilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. #J-18808-Ljbffr