MDR - MDR/Vigilance Specialist
18000 Devonshire Street Sherwood Forest, CA 91325 US
Job Description
Top 3 Skills:
- Medical device experience. Preferably Diabetes.
- Medical Background with the ability to understand complex disease states and different treatment outcomes.
- Certified personnel with clinical knowledge and relevant patient care experience (e.g. RN, CDE, MD,PA, RD) or Biomedical Engineer.
Education Required: Bachelor’s degree with a minimum of 4 years of medical safety experience or advanced degree with a minimum of 2 year medical safety experience.
Years’ Experience Required: Minimum of 4 years of medical safety experience or advanced degree with a minimum of 2 year medical safety experience.
Responsibilities may include the following and other duties may be assigned.
- Provides medical expertise and assessment as it relates to device functionality and patient safety outcomes.
- Applies technical and clinical knowledge regarding product usage and performance, specifically as it relates to patient safety and relationship of the reviewed severe adverse event or death to the device in use.
- Applies knowledge of Medtronic Diabetes products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e.hazards and harms) to assessment of medical review outcomes.
- Leverages medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes for new product assessments.
- Escalates events and potential safety signals identified through complaint reviews to the office of Medical Affairs for additional assessment.
- Collaborates with Office of Medical Affairs/Medical Safety, Risk Management, 24 Hr. HelpLine, Quality/Engineering and Failure Analysis to make accurate assessments of patient pump and device usage
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree with a minimum of 4 years of medical safety/medical affairs experience, or advanced degree with a minimum of 2 years medical safety/medical affairs experience.
- Nice to Have (Preferred Qualifications)
- Diabetes medical device experience highly preferred.
- Medical background with the ability to understand complex disease states and different treatment outcomes
- Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, CDE, MD, PA, RD) or Biomedical Engineer.
Add in Travel if applicable
Ability to travel up to 10% domestically as needed.
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