Product Surveillance Associate

1 week ago

Trumbull, CT, United States Cooper Companies Full time
Job Description

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.

Responsibilities

  • Evaluates incoming complaint information and maintains it in the electronic database.
  • Works closely with customers and sales representatives to obtain additional complaint information and respond to complaint reports.
  • Determines reportability (MDR/Adverse Event) of complaints to FDA and other international regulatory agencies.
  • Closely monitors 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.
  • 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.
Travel: None

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.
Education:
  • Bachelor's Degree in healthcare related or technical field

#LI-KA1

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.

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