Especialista en vigilancia post

Snapshot of the Candidate’s Day: As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating initial periodic product PSURs / post market surveillance reports. 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. In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities. How the Candidate Will Make an Impact: Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including: 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. · Maintain, archive and completed controlled quality records. Coordinate PMS deliverables with internal business partners. Manage and assure Post Market Performance Follow up deliverables are completed on 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) 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 lifescience/technical/engineering discipline or 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.