VIGILANCE SPECIALIST
Moundsview, MN · On-site
Associated MDR/Vigilance Specialist Location: Mounds View, MN Duration: 12+ months (Possibility of extension) ROLES & RESPONSIBILTIES Participates in the company's medical device and/or drug ...
Moundsview, MN · On-site
Associated MDR/Vigilance Specialist Location: Mounds View, MN Duration: 12+ months (Possibility of extension) ROLES & RESPONSIBILTIES Participates in the company's medical device and/or drug ...
Moundsview, MN · On-site
Associated MDR/Vigilance Specialist Location: Mounds View, MN Duration: 12+ months (Possibility of extension) ROLES & RESPONSIBILTIES Participates in the company's medical device and/or drug ...
Saint Paul, MN · On-site
Vigilante Specialist Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and ...
Saint Paul, MN · On-site
Vigilante Specialist Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and ...
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 ...
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 ...
Associate MDR/Vigilance Specialists are responsible for theintake, documentation, Medical Device Reporting, and investigation of complaintsfor legacy Neuromodulation products in accordance with ...
Associate MDR/Vigilance Specialists are responsible for theintake, documentation, Medical Device Reporting, and investigation of complaintsfor legacy Neuromodulation products in accordance with ...
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
Morrisville, NC · On-site
$90 - $120/hr
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
Morrisville, NC · On-site
$90 - $120/hr
Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...
ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
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ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
ENROLLMENT SPECIALIST (Bilingual) Who We Are Vigilance Health partners with FQHCs, ACOs, IPAs, and payers to deliver Population Health and Care Management services that actually move the needle. We ...
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Moundsview, MN · On-site
$25 - $27/hr
Job Title: Medical Device Complaint Specialist Client: Medical Device Manufacturing Company ... Prepare and submit MDR, Vigilance Reports (VR), and Adverse Drug Experience (ADE) reports.
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Moundsview, MN · On-site
$25 - $27/hr
Job Title: Medical Device Complaint Specialist Client: Medical Device Manufacturing Company ... Prepare and submit MDR, Vigilance Reports (VR), and Adverse Drug Experience (ADE) reports.
Ewing Township, NJ · Remote
$35 - $40/hr
Global Complaint QA Specialist Location: Ewing, New Jersey Type: Contract Compensation: $35-$40/hr ... Coordinate complaint follow-ups with vigilance and global contact center partners to ensure all ...
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Ewing Township, NJ · Remote
$35 - $40/hr
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Moundsview, MN · On-site
$24 - $27/hr
Job Title: Medical Device Complaint Specialist Client: Medical Device Manufacturing Company ... Maintain accurate complaint and vigilance records * Analyze safety and clinical data for reporting ...
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Moundsview, MN · On-site
$24 - $27/hr
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Ewing Township, NJ · Remote
$35 - $40/hr
Global Complaint QA Specialist Location: Ewing, New Jersey Type: Contract Compensation: $35-$40/hr ... Coordinate complaint follow-ups with vigilance and global contact center partners to ensure all ...
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Ewing Township, NJ · Remote
$35 - $40/hr
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Ewing Township, NJ · Remote
$35 - $40/hr
Global Complaint QA Specialist Location: Ewing, New Jersey Type: Contract Compensation: $35-$40/hr ... Coordinate complaint follow-ups with vigilance and global contact center partners to ensure all ...
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Ewing Township, NJ · Remote
$35 - $40/hr
Global Complaint QA Specialist Location: Ewing, New Jersey Type: Contract Compensation: $35-$40/hr ... Coordinate complaint follow-ups with vigilance and global contact center partners to ensure all ...
Thousand Oaks, CA · On-site
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Thousand Oaks, CA · On-site
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Los Angeles, CA · On-site
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Moundsview, MN • On-site
Full-time
Medical, Life
Re-posted 16 days ago
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job title: Associated MDR/Vigilance Specialist
Location: Mounds View, MN
Duration: 12+ months (Possibility of extension)
ROLES & RESPONSIBILTIES
Participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports.
The MDR Specialist analyzes events reported from multiple inputs on Cardiac Rhythm and Heart Failure Management (CRHF) products to determine complaint status and regulatory reportability.
In addition, this position supports the ongoing monitoring of product performance.
Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies.
Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information.
Supports and represents complaint handling in internal and external audits and inspections.
As part of the Cardiac and Vascular Group Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.
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.
***Required***
Bachelor's Degree
At least one year experience in a health, clinical, technical, or scientific field
Can work independently in a team environment
Attention to detail
We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732 - 318 -6506 | (W) # 732-549-2030 - Ext - 324 | (F) 732-549-5549
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Recruiting and staffing services
51 - 200 Employees
Edison, NJ, US
1996