Tuesday, May 10, 2011

Medical Device Review (MDR) Specialist - St. Jude Medical, Plano, TX

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The MDR (Medical Device Review) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting

Major Ongoing Responsibilities:

• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality

• Complete FDA MDR and DDR annual baseline reporting

• Perform analysis of complaint data

• Handle complaint investigations, which may include coordinating activities with Reliability, Servicing, Customer Service, or communicating with the Sales Representative, Physician, and /or Customer

• Documents events and findings effectively and logically

• Communicates (verbal and written) in a professional and courteous manner

Education and Training:

• Bachelors degree or relevant experience with an Associates degree in a clinical/medical discipline is required

• 3+ years related experience in post market surveillance in a Medical Device or Pharmaceutical Industry

• 1+ MDR and DDR experience required

• Knowledge of the use, development, and regulatory environment of medical devices

• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting

• Quality focused, attentive to detail and results oriented

• Ability to work independently in fast-paced environment with little supervision

• Familiar with ISO Regulations 14971, 13485

• Computer literate, Word, Excel

• Six Sigma Green Belt training a plus

• Ability to learn quickly and multi task

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