Trumbull, United States
3 months ago
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Product Surveillance Associate in Trumbull, CT.
Position Summary and Special Duties:
As a (an) Product Surveillance Associate your day to day duties will consist of and may not be limited to:
Product Surveillance Associate (Contract)
The Product Surveillance Associate primarily supports all recall or field safety correction activities, in addition to reviewing, evaluating, and investigating 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.
- 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.
- Provides guidance and training to support staff and new associates.
- Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations.
- Performs additional duties or assignments as required by management.
- Bachelor's Degree preferred or equivalent experience in healthcare related or technical field. One year of previous experience required.
- 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)
- A writing sample from the candidate will be needed to accompany email submission (this may be a publication, research paper from school, etc.).
- Candidates should have excellent writing skills.
- New science grad with experience writing proposals, grants, publications, etc. would be excellent.
- Please schedule a 1 hour interview.
- Duration: Temp Long term
- Location: Trumbull, CT.
- Salary: $20-$25hr.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.