Product Surveillance Associate
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Job Location:
Trumbull, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.
Work location: Trumbull CT or Dallas TX (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 effectivenessof 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 includesupporting 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:
- Bachelors Degree in healthcare related or technical field
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Our Benefits:
As an employee of CooperSurgical youll 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 atto 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 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.
Required Experience:
IC
Key Skills
- Marketing
- Quality Assurance
- Agile
- Product Demos
- Analysis Skills
- Jira
- Project Management
- Product Management
- Qualitative Analysis
- Confluence
- Internet Of Things
- Product Development
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.
