CRS I at Minneapolis

Job Description

POSITION DESCRIPTION: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. Identify and initiate product event investigations to satisfy MDR/ADR requirements.POSITION RESPONSIBILITIES: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, Company field personnel and/or physicians/customers as appropriate.Initiate and complete 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.BASIC QUALIFICATIONS:2+ years of regulatory experience with Bachelor Degree or Masters DegreeDESIRED/PREFERRED QUALIFICATIONS (optional):2-5 years experience in healthcare or medical devise/pharmaceutical industry in safety or clinical data evaluationKnowledge of medical events and good analytical skills computer literateGood communication skills, oral and written; ?Complaint handling experience and customer service/technical support experienceHigh level of computer proficiencyKnowledge of Neuro productsKnowledge of 21CFR, Section 820, Quality System Regulation 21CFR803, Medical Device Reporting 45CFR, Parts160 and 164, Patient Privacy Rule- HIPPA 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)

Job Requirements

 
Country: USA, State: Minnesota, City: Minneapolis, Company: InVentiv Health.