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MEDICAL DEVICE REPORTING (MDR) SPECIALIST
Job Field: Environmental Jobs
Location: Sunnyvale, CA
Salary: $Not stated
Location: Sunnyvale, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Medical Device Reporting (MDR) SpecialistTracking Code329Job DescriptionInterface with quality, regulatory, clinical education, technical service and sales representatives as needed.  Conduct investigations for reported complaints, MedWatches and other vigilance reports.  Assist in data collection and reporting for trending purposes.  Contribute in continuous improvement initiatives. Required Skills• Investigate product complaint events by coordinating with internal resources, field employees, and international staff as appropriate• Collaborate with appropriate clinical, technical, and/or returned product analysis employees to determine product event status and MDR reportability• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints• Write and submit MDR reports to the FDA in strict adherence with regulatory requirements and timelines; performs MDR searches/queries, conduct data analysis and develops reports for management review as required• Maintain complaint and MDR file documentation in accordance with regulatory requirements.  Completes global complaint handling and adverse event reporting activities related to our products.  Submits global vigilance reports as required.• Facilitates successful team behavior within the company by promoting cross-functional and cross-departmental support• Provide training to employees regarding MDR, complaint-handling, and applicable global regulatory requirements• Provide support for internal quality audits of complaint files / MDR documentation• Comply with the site Quality System• Perform other duties as assigned Required Experience• 3 – 5 years of MDR experience with Bachelor’s Degree, or 1 – 3 years of MDR experience with Master’s Degree• Nursing certification preferred, other allied health certification accepted• Familiarity with tracking and trending processes or statistical techniques• Excellent oral and written communication skills• Strong interpersonal and organizational skills• Strong presentation skillsJob LocationSunnyvale, California, United StatesPosition TypeFull-Time/Regular
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<tr><td valign="top" width="450"><b>Medical Device Reporting (MDR) SpecialistTracking Code329Job DescriptionInterface with quality, regulatory, clinical education, technical service and sales representatives as needed.  Conduct investigations for reported complaints, MedWatches and other vigilance reports.  Assist in data collection and reporting for trending purposes.  Contribute in continuous improvement initiatives. Required Skills• Investigate product complaint events by coordinating with internal resources, field employees, and international staff as appropriate• Collaborate with appropriate clinical, technical, and/or returned product analysis employees to determine product event status and MDR reportability• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints• Write and submit MDR reports to the FDA in strict adherence with regulatory requirements and timelines; performs MDR searches/queries, conduct data analysis and develops reports for management review as required• Maintain complaint and MDR file documentation in accordance with regulatory requirements.  Completes global complaint handling and adverse event reporting activities related to our products.  Submits global vigilance reports as required.• Facilitates successful team behavior within the company by promoting cross-functional and cross-departmental support• Provide training to employees regarding MDR, complaint-handling, and applicable global regulatory requirements• Provide support for internal quality audits of complaint files / MDR documentation• Comply with the site Quality System• Perform other duties as assigned Required Experience• 3 – 5 years of MDR experience with Bachelor’s Degree, or 1 – 3 years of MDR experience with Master’s Degree• Nursing certification preferred, other allied health certification accepted• Familiarity with tracking and trending processes or statistical techniques• Excellent oral and written communication skills• Strong interpersonal and organizational skills• Strong presentation skillsJob LocationSunnyvale, California, United StatesPosition TypeFull-Time/Regular
KEY REQUIREMENTS:
Not stated
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