Product Surveillance Associate

CooperSurgical

Trumbull, CT

Report to: Product Surveillance Manager

The Product Surveillance Associate reviews and evaluates product complaints relative to the identity, quality, 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. Tasks also include supporting the intake of complaints from multiple 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, and several complaint process activities.

You Will:

• Evaluate incoming complaint information and maintain it in the electronic database.
• Work with customers and sales representatives to obtain additional complaint information and respond to complaint reports.
• Determine reportability (MDR/Adverse Event) of complaints to FDA and other international regulatory agencies.
• Monitor quality, completeness, and timeliness of complaint intake information, reportability assessments, and investigation assignments.
• Triages and escalates product/ patient safety or compliance issues to management for immediate attention.
• Participate in team, weekly reportability assessments.
• Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations.
• Perform additional assignments by management.

You Have:

• Bachelor's Degree preferred or equivalent experience in healthcare related or technical field. One year of previous experience required.
• Demonstrated experience prioritizing conflicting demands.
• Excellent verbal, written, presentation skills with attention to detail and the ability to communicate business issues.
• Operating knowledge of MS Office suite (Outlook, Word, & Excel (can maintain complex spreadsheets)).

CooperSurgical is a market leader in the development, production, and marketing of medical devices used to promote women's health care and minimally invasive surgery. It is an exciting, ever-evolving, and market that touches all our lives.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.