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MDR/Vigilance Specialist
Collabera Mounds, MN
$72k-85k (estimate)
Full Time | IT Outsourcing & Consulting 3 Months Ago
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Collabera is Hiring a MDR/Vigilance Specialist Near Mounds, MN

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

Job Summary

JOB TYPE

Full Time

INDUSTRY

IT Outsourcing & Consulting

SALARY

$72k-85k (estimate)

POST DATE

03/14/2024

EXPIRATION DATE

08/05/2024

WEBSITE

collabera.com

HEADQUARTERS

REDMOND, WA

SIZE

3,000 - 7,500

FOUNDED

2005

CEO

ADITI OGALE

REVENUE

$500M - $1B

INDUSTRY

IT Outsourcing & Consulting

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About Collabera

We are engineering technology & talent. At Collabera, we built our business and our reputation by servicing the engineering solutions and talent development needs of our clients. That experience helped make us who we are todaypartners with the worlds most forward-thinking organizations, designing, building, operating and automating the technology that powers their businesses. Every solution we provide is delivered with speed, scale, quality, and flexibility, and powered by our AI-driven, Cloud-based technology and talent platforms. And, while weve expanded our offerings to meet the evolving ne ... eds of our software engineering clients, we havent forgotten where we came fromwere still committed to building the tech workforce of the present and the future through our best-in-class training and enablement services. In other words, were driven by tech and backed by talent. Its that human-centric approach that makes us unique. And it reminds us that relationships are always the most important things we build. So, whether you need innovative technology talent solutions, or youre looking for opportunities to work with todays most tech-forward organizations, partner with usand let us help your business or your career get to the next level. More
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