Product Surveillance Associate
Collabera Inc.
Product
Mounds View, MN, USA
USD 23-27 / hour
Posted on Jun 12, 2025
Product Surveillance Associate
Contract: Mounds View, Minnesota, US
Salary Range: 23.00 - 27.00 | Per Hour
Job Code: 362823
End Date: 2025-07-11
Days Left: 28 days, 9 hours left
To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!
Pay rate: $23 - $27/hr.
Responsibilities:
- Apply policies and procedures to comply with FDA and OUS regulations.
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
- Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
- Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
- Maintain awareness of new products, government regulations and requirements.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Other duties as assigned.
Must Have:
- To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor degree
- High level of computer proficiency (e.g. Office, SAP, Siebel, Oracle Clinical, etc)
- 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have:
- Degree in Health Care, Sciences, or Bio-Medical Engineering
- Medical device industry experience
Job Requirement
- FDA regulations
- Medical Device Reporting
- Vigilance reporting
- Adverse Event Reporting
- Regulatory submissions
Reach Out to a Recruiter
- Recruiter
- Phone
- Deepak Arya
- deepak.arya@collabera.com