Collabera
MDR/Vigilance Specialist
Collabera, Mounds View, Minnesota, United States,
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.Job Description
Position 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.Qualifications
Basic Qualification:Education Required:
Bachelor's DegreeYears Of Experience:
Less than one year experience in a health, clinical, technical, or scientific field with a Bachelor’s Degree.Additional Information
If you want to apply and want to know more, please contact:
#J-18808-Ljbffr
Position 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.Qualifications
Basic Qualification:Education Required:
Bachelor's DegreeYears Of Experience:
Less than one year experience in a health, clinical, technical, or scientific field with a Bachelor’s Degree.Additional Information
If you want to apply and want to know more, please contact:
#J-18808-Ljbffr