Especialista en vigilancia post - mercado Jr

Puesto: Especialista en vigilancia post - mercado Jr.
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.

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.
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.
Bachelor’s degree or equivalent in a related life science/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.
Advanced technical writing and word processing skills.

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.