Medical Device Reporting Specialist
||Thursday, June 8, 2017
CONMED is committed to developing high quality, innovative medical device products to improve the quality of life for our customers around the globe. As an Medical Device Reporting Specialist you will review and process domestic and international complaints for Medical Device Reporting (MDR) and International FAR/(Vigilance) Device reporting requirements based on FDA Regulations and International [Medical Device Directive (MDD)] Device Reporting requirements. You will assist in clinical rationale for non-reportable events based upon surgical experience, medical opinion, professional literature and the Association of Operating Room (AORN) Standards. You will assist with documentation of Clinical Opinions and Health Hazard Evaluations as requested.. Your specific job responsibilities will include:
- Review incoming domestic and international complaints on a daily basis to determine reportability based on FDA Regulations (MDR) and Medical Device Directive (MDD) reporting requirements and other Regulatory Bodies as required.
- Generate sound rationales for non-reportable events based on regulatory knowledge and/or clinical experience.
- Contact the customer/user and/or other resources to gather patient/incident information to aid in reportability decision.
- Document MDR, Vigilance, Foreign Adverse Event Reporting decisions under the supervision of the Supervisor or Manager.
- Complete, prepare and submit MDR, VIG, FAR reports within the timeframes specified by Regulations. Process all reportable events to closure per domestic and international regulations and internal procedures.
- Provide assistance to International Affiliate Regulatory Manager/Associate as needed to ensure VIG and FAR reports are accurately completed and submitted.
- Prepare and send complaint written replies/letters to the customers and international affiliate/distributor as requested..
- Review Evaluation Result reports to prepare and complete Preliminary Investigations to ensure complaints are processed and closed within the required timeframe.
- Participate in corrective/preventive action and product design team meetings as required. Provide technical input to the investigation team and product design teams as needed.
- Assist in Health Hazard Analysis by contributing and reviewing Risk Assessments.
- Individually responsible for maintaining a high level of knowledge in products, surgical techniques, professional certifications/license and FDA Regulations.
- One to Two years experience in the Regulatory field or Medical field
- Knowledge/experience in GMP/QRS regulations and MDR/MDD reporting requirement
- Certified Surgical Technician (CST)
- Nurse, BS in Science, Engineering or related field or equivalent experience in Quality or Regulatory industry
- Basic to skilled knowledge of computer including Excel, Access and word-processing
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