What are the responsibilities and job description for the MDR/Vigilance Specialist position at Collabera?
Company Description
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 Degree
Years 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:
Sagar Rathore
sagar.rathore(AT)collabera.com
630-485-2166
