Medical Device Reporting (MDR) Specialist
Location: Mounds View Minnesota
Description: Humera is at the momment seeking for Medical Device Reporting (MDR) Specialist right now, this career will be placed in Minnesota. For complete informations about this career opportunity please give attention to these descriptions. Humera has an opportunity for a Medical Device Reporting Specialist! This 2 year-long, contract opportunity is working for our client, the worl! d leader in Medical Device Technology and Therapies! This fortune 500 company is committed to innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease. Our client is committed to innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease. This position is working with the company's compliance investigation area, which involves working across the organization on different products and patient experiences.
Electronically process complaint events and complete identified medical device report forms (MDR) as required per internal and FDA regulations/standards
Ensure compliant investigations are adequate, accurate and timely
Meet daily team and individual output goals
Perform investigation tasks to obtain adequate information to ensure proper documentation and closure of each complaint
Collaborate with appropriate technical, clin! ical, and/or returned product analysis employees to determine ! reporting eligibility
Electronic submission of MDR files to the FDA
Provide user testing and validation support for software applications
Perform MDR search/queries, conduct data analysis and develop reports for management review
Data entry, scanning and retention of documents to complete event files
Develop and maintain product knowledge of CRDM existing and new products
Assist in inspection support for FDA and worldwide regulatory agencies. This may include coordination, research, and preparation correspondence in response to global regulatory agencies requests for additional information
Provide training to CRDM new and other employees regarding MDR, complaint-handling and applicable global regulatory requirements
Complete special projects as assigned and required specific to the medical device reporting process as a result of new acquisitions, business realignment or new regulations or standards
Continue ongoing training of U! S current reporting regulations and standards (compliance training)
Bachelor's Degree in Nursing, Pre-med or Biomedical Science
At least 3 years of experience in Medical Device Reporting, Medical Device Complaint Handling, Regulatory Affairs, or Clinical Research. Or at least 3 years of experience in an Engineering role with product knowledge and/or FDA regulations
At least 3 years of professional experience
Direct experience with MDR reporting or complaint handling
Knowledge of 21 CFR Part 820, Quality System Regulations
Knowledge of 21 CFR Part 803, Medical Device Reporting
Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statue
Ability to learn
Excellent communication skills
Ability to work well on a team
Experience with web based systems is very helpful
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Humera.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Mon, 27 May 2013 09:24:55 GMT