Product Surveillance Associate

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments.

Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Learn more at www.coopersurgical.com .

Work location: Trumbull, CT (on-site)

Scope: Post Market Surveillance complaint entry and support of MDR/MDV reporting.

Job Summary: The Product Surveillance Associate reviews and evaluates product complaints relative to the identity, quality, reliability, safety, and effectiveness of CooperSurgical Medical Device and Invitro Fertilization products.

The Product Surveillance Associate is experienced in complaint handling activities and categorizing complaints to comply with current FDA and international reporting regulations.

Duties also include supporting the intake of complaints from various sources, initial screening of essential complaint details, Good Faith Effort Follow ups for additional information, Medical Device Reporting (MDR)/Medical Device Vigilance (MDV) determination, investigation assignment, as well as various complaint process activities.

The Product Surveillance Associate must have excellent customer service skills, the ability to evaluate, disseminate, and present information from a global perspective.