Medical Device Product Safety Analyst (Entry/Junior Level)

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.

Requirements: Bachelor's Degree within some type of Science (Biology, etc) or Biomedical Engineering 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 Strong verbal and written communication skills Knowledge of basic anatomy and physiology Strong attention to detail High level of computer proficiency Seniority level Entry level Employment type Contract Job function Analyst Industries Biotechnology Research and Medical Equipment Manufacturing