Humera - Administrative and Professional Staffing

Medical Device Reporting (MDR) Specialist

Fridley, MN, USA
Contact For Rate
Sep 09, 2013
Sep 12, 2013
Customer Service
Job Type
Employment Status
Full Time
Job Description:
Humera Administrative and Professional Staffing is seeking 4 Medical Device Reporting (MDR) Specialists for our client located in Fridley! In this role you will evaluate adverse events involving Neuromodulation products to determine MDR/ADR eligibility, report MDR/ADR eligible events to the FDA within the MDR/ADR regulatory requirements and identify and initiate product event investigations to satisfy MDR/ADR requirements. These are short term contracted assignments.
  • Evaluate incoming field reports, product returns and product analysis results for Neuro products to determine Medical Device Reporting (MDR) eligibility and Adverse Drug Experience Report (ADR) eligibility
  • Investigate specific events by contacting internal resources, field personnel and/or physicians/customers as appropriate
  • Initiate and complete MedWatch reports for timely submission to the FDA
  • Maintain awareness of new products, government regulations and requirements
  • Develop and maintain integrated system post market safety reports for both drugs and devices
  • Provide input on internal system and methods to maintain MDR/ADR compliance and support post-market surveillance
  • Liaison with pharmaceutical partners regarding investigating and reporting of any adverse events reporting globally
  • Ensure personal understanding of all quality policy/system items that are personally applicable
  • Follow all work/quality procedures to ensure quality system compliance and high quality work

Required Skills, Knowledge, and Abilities:
  • Bachelor Degree or Masters Degree
  • 2+ years of regulatory experience
  • 2-5 years experience in healthcare or medical devise/pharmaceutical industry in safety or clinical data evaluation
  • Knowledge of medical events and good analytical skills computer literate
  • Excellent verbal and written communication skills
  • Complaint handling experience and customer service/technical support experience
  • High level of computer proficiency
  • Knowledge of Neuro products
  • Knowledge of 21CFR, Section 820, Quality System Regulation 21CFR803, Medical Device Reporting 45CFR, Parts160 and 164, Patient Privacy Rule- HIPAA Regulations ISO 13485, Quality Systems, Quality Management Systems AIMD Directive: 90/385/EEC IVD Directive: 98/97/EC MDD Directive (Council Directive 93/42/EEC for Medical Devices) PC 1998-783 - Canadian Medical Device Regulation (CMDR)

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