Medical Device Product Safety Analyst; Entry​/Junior Level

Medical Device Product Safety Analyst (Entry/Junior Level)

ONSITE WORK 4 DAYS/WEEK

Our client, a leading Medical Device company, is seeking an entry/junior level Product Safety Analyst. This role is ideal for someone who recently completed a Bachelor's Degree and has an interest in the medical device field. There is robust training.

• 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.

• 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

• 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

Entry level

Contract

Analyst

Biotechnology Research and Medical Equipment Manufacturing