What are the responsibilities and job description for the Regulatory Specialist, Medical Devices position at Primary Talent Partners?
Primary Talent Partners has a 2 year contract opening for a Medical Device Regulatory Specialist to join a multinational medical device company for a hybrid position operating out of Mounds View, MN.
Pay: $32.00/hr - $37.00/hr based on experience
Contract: 2 years, conversion possible
Type: W-2, Cannot support C2C or provide Visa Sponsorship
Hybrid:Onsite 2 - 3 days a week in office (Hybrid) - Core hours are 9am - 3pm M-F.
Responsibilities:
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Pay: $32.00/hr - $37.00/hr based on experience
Contract: 2 years, conversion possible
Type: W-2, Cannot support C2C or provide Visa Sponsorship
Hybrid:Onsite 2 - 3 days a week in office (Hybrid) - Core hours are 9am - 3pm M-F.
Responsibilities:
- The top 3 responsibilities associated with this position include
- Creating Regulatory Reporting on potential complaints regarding medical devices
- Project Support
- Working collaboratively with the rest of the team.
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Bachelor's degree is required, ideally in a scientific or engineering discipline.
- 1-3 years of experience minimium
- Medical Background and/or experience working for medical device manufacturer.
- Cardiovascular experience would be beneficial
- Experience working in a very regulated work environment
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Salary : $32 - $37
