Product Surveillance Communications Associate

Product Surveillance Communications Associate

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.

Work location : Trumbull, CT (on-site)

Scope : Post market surveillance investigation letters / reports provided to customers for filed complaints.

Job Summary :

The Product Surveillance Communications Associate is responsible for reviewing complaint investigations and drafting effective customer letters / reports in a timely manner relevant to KPI metrics. Customer investigation letters are needed for global medical device and invitro fertilization (IVF) product complaints to ensure high levels of customer satisfaction and professionalism. The Product Surveillance Communications Associate must have excellent writing skills, customer service skills, and the ability to evaluate, disseminate, and present information from a global perspective.

Responsibilities

Evaluates complaints closed on a weekly basis that require letters and maintains data in an electronic database / tracker.

Closely monitors quality, completeness, and timeliness of complaint letters / reports to customers and sales representatives.

Works closely with product managers and engineers to obtain any additional investigation details as needed.

Triages and escalates product / patient safety or compliance issues to management for immediate attention.

Participates in team decision making, weekly reportability assessments, and displays team problem solving / communication skills.

Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations.

Performs additional duties or assignments as required by management.

Qualifications

Knowledge, Skills and Abilities :

Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

Ability to work independently and in a team setting.

Excellent verbal, written, presentation skills with attention to detail and the ability to communicate business issues clearly.

Strong operating knowledge of MS Office suite (Outlook, Word, & Excel).

Experience :

One to three years of previous experience required drafting letters / correspondence to customers.

Education :

Bachelor's Degree in healthcare related or technical field.

Our Benefits :

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.

To all agencies : Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms / employment agencies to any employee at CooperSurgical via-email, the internet or in any form and / or method will be deemed the sole property of CooperSurgical, unless such search firms / employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

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.