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MDR (medical device reporting) Specialist - 63440422 - TT

Job Code: 63440422
Job Location: Mounds View, MN
Category: Quality Engineering
Last Updated: 12/04/2018
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Job Description:
Medical Device Reporting Specialists (2 openings)
1. Science, chemistry, biology or engineering background is helpful
2. Complaint handling experience is helpful
Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections.  
Responsibilities:
• Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.
• Ensure complaint investigations are adequate, accurate, detailed and timely.
• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
• Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
• Complete electronic submission of MDRs to the FDA.
• Ensure accurate data entry, scanning, and retention of documents to complete event files.
• Support internal systems, methods, and procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF products.
• Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.
• Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.
• Complete projects as assigned and required specific to post-market quality and complaint handling.
 
Requirements:
EDUCATION REQUIRED:
Bachelor's Degree- Science, chemistry, biology or engineering
YEARS OF EXPERIENCE:
Less than one year experience in a health, clinical, technical, or scientific field with a Bachelor’s Degree
DESIRED/PREFERRED QUALIFICATIONS:
• Knowledge of CRHF products and therapies
• Experience in a clinical or regulated environment
• Lean Sigma Experience (Green Belt/Black Belt)
• Experience with complaint handling, MDR/Vigilance reporting
• Knowledge of 21 CFR Part 820, Quality System Regulations
• Knowledge of 21 CFR Part 803, Medical Device Reporting, 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 63440422TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 

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