Medical Device Product Safety Analyst (Entry/Junior Level)

Planet Pharma; Minneapolis (MN); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading Medical Device company is seeking an entry/junior level Product Safety Analyst to ensure compliance with FDA regulations. Ideal for recent graduates, the role involves monitoring medical device safety and submitting necessary reports. Strong communication and attention to detail are essential. The position is contract based with onsite work four days a week.

Qualifications

• 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation.

Responsibilities

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitor the company's medical devices surveillance program.
• Evaluate incoming information for Medical Device Reporting eligibility.
• Ensure timely submission of Medical Device Reports (MDRs).
• Liaise with internal and external contacts for complaint collection.

Skills

Strong verbal and written communication skills

Strong attention to detail

High level of computer proficiency

Education

Bachelor's Degree in Science or Biomedical Engineering

Job description

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.

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