Responsibilities:

• 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: 

• To be considered for this role, please ensure the minimum requirements are evident on your resume.
• Bachelor degree
• High level of computer proficiency (e.g. 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 Health Care, Sciences, or Bio-Medical Engineering
• Medical device industry experience