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
Nice to Have
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
Numbers & Facts
Location
Mounds View, MN
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Skills
Adverse Eventsunmatched
Anatomyunmatched
Biologyunmatched
Biomedical Engineeringunmatched
Biotech and Pharmaceuticalunmatched
Clinical Assessmentunmatched
Clinical Dataunmatched
Clinical Medicineunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Customer Relationsunmatched
Data Analysisunmatched
Detail Orientedunmatched
FDA Requirementsunmatched
Government Regulationsunmatched
Government Requirementsunmatched
Healthcareunmatched
Medical Equipmentunmatched
Medical Recordsunmatched
Microsoft Officeunmatched
Nursingunmatched
Oracleunmatched
Pharmacovigilanceunmatched
Physiologyunmatched
Presentation/Verbal Skillsunmatched
Protocol Analysisunmatched
Regulationsunmatched
Regulatory Reportsunmatched
Regulatory Requirementsunmatched
SAPunmatched
Siebelunmatched
Surveillanceunmatched
Time Managementunmatched
Writing Skillsunmatched
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