A medical device company is seeking an Associate MDR / Vigilance Specialist for a 24 month contract. Candidates will be required to be onsite 2 days per week - Wed and Thurs - in Mounds View, MN.
HM Top 3 :
- Strong attention to detail
- Strong analytical skills (problem solving critical thinking)
- Strong writing skills
Description :
Associate MDR / Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies).
Education Required : Bachelor’s degree
Primary Responsibilities :
- Reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system.
- Determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission.
- Conducting follow-up with internal and external contacts to ensure complete complaint information is obtained as well as evaluating incoming information for Medical Device Reporting and Vigilance Reporting eligibility.
Additional Duties :
- 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.
Must Have :
- Bachelors degree with 0 years’ experience in healthcare or medical device / pharmaceutical industry in safety or clinical data evaluation
- Strong attention to detail, strong analytical skills, strong writing skills (oral and written)
Nice to Have :
- High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
- Strong preference for 0-2 years’ experience in healthcare
- Also interested in candidates with experience in medical device / pharmaceutical industry in safety or clinical data evaluation
- Bachelor’s Degree in Health Care, Sciences, or Bio-Medical Engineering
- Knowledge of basic anatomy, physiology, and medical terminology
- Complaint handling experience or customer service / technical support experience (0-2 years)
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