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Humera - Administrative and Professional Staffing

Medical Device Reporting (MDR) Specialist

This job has now expired

Humera - Administrative and Professional Staffing
Monday, September 9, 2013
Thursday, September 12, 2013
Fridley, MN, USA
Job Type
Employment Status
Contact For Rate

Further information

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)

Humera - Administrative and Professional Staffing

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