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Assoc MDR/Vigilance Spec - Exempt
HireTalent
🇺🇸 United States
On-site
2 months ago
- SAP
- Oracle
2 months ago
Not enough detail in this posting to match
Job Location - 8200 Coral Sea Street NE, Mounds View, MN
Duration: 24 Months
Job Description -
HM's Top Needs:
1. Nursing/medical backgrounds (ideally with clinical experience working with medical devices)
2. Biomedical engineering or biomedical neuroscience backgrounds (education without on-the-job experience is sufficient)
3. Pre-med, pre-vet educations (essentially, any degree with a heavy focus on biological sciences including anatomy, physiology, etc.)
Education Required:Bachelors Degree
Years’ Experience Required:0-2 years
Responsibilities include the following but not limited to:
- 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: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor of science degree
- High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
- 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
- Degree in nursing, biology/pre-med or pre-vet, or biomedical engineering
- Medical device industry experience
- Strong verbal and written communication skills
- Knowledge of basic anatomy and physiology
- Strong attention to detail
- High level of computer proficiency
Assoc MDR/Vigilance Spec - Exempt · HireTalent