Veracord is a consulting firm that supports Life Science companies with a wide range of needs related to Quality, Manufacturing, Validation & Compliance. Our client located in the Bay Area has an immediate opening for a Clinical Product Surveillance Analyst.
This position is with a Fortune 100 Medical Device Company in the Santa Clara County.
Please email resumes to: firstname.lastname@example.org
Clinical Prod Surveillance Analyst
· Accountable for the professional medical analysis and validation of product surveillance documents, medical device reports (MDRs), and customer letters.
· Analyzes customer inquiries to ensure company responses are medically appropriate and include relevant, accurate, and thorough technical, clinical, and educational information while communicating directly with the customer.
· Makes recommendations to management based on these analyses.
· Reviews and validates product surveillance documents and medical device reports for patient safety and product efficacy. Stays abreast of and communicates developments to ensure that product surveillance files comply with U.S. Food and Drug Administration (FDA) regulations as well as company policy.
· Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study.
· Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
· Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues.
· Exercises independent judgment in planning and organizing work; monitors performance and reports status.
· Bachelors of Science Degree in Nursing (BSN) and a current nursing license, or a BS or MS in Biomedical Engineering,
· A minimum of six months of relevant experience in clinical risk analysis/or technical support in the cardiac pacing industry, or equivalent.
· Candidate must demonstrate strong written and oral communication skills.
· Demonstrated ability to understand, interpret, and comply with US Food and Drug Administration (FDA) regulations and Company operating procedures. Must be able to demonstrate the ability to read and interpret medical reports as well as product documentation.
· Candidate must possess demonstrated organizational skills, professional and business judgment, sound decision-making and problem-solving abilities, discretion, and excellent organizational skills for managing multiple ongoing tasks.