TEMP_NEO_FDA regulatory compliance

Associate MDR/Vigilance Specialist – Exempt

Job Location:

8200 Coral Sea Street NE, Mounds View, MN 55112 Duration: 24 Months Payrate: $28.57/hr on W2

Job Description:

HM's Top Needs:

• Nursing/medical backgrounds (ideally with clinical experience working with medical devices)
• Biomedical engineering or biomedical neuroscience backgrounds (education without on-the-job experience is sufficient)
• 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