MDR/Vigilance Specialist

Reposted One Month Ago
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Mounds View, MN, USA
In-Office
Entry level
Information Technology • Software
The Role
The MDR/Vigilance Specialist processes complaint events, prepares Medical Device Reports, conducts investigations, ensures compliance and supports regulatory inspections.
Summary Generated by Built In
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

Skills Required

  • Bachelor's Degree
  • Less than one year experience in health, clinical, technical, or scientific field

Collabera Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Collabera and has not been reviewed or approved by Collabera.

  • Fair & Transparent Compensation Pay is considered acceptable to strong on select technical contracts and in certain geographies, with some assignments described as substantially above typical consultant rates. Outcomes appear closely aligned to client budgets and market conditions, delivering solid value in higher‑demand niches.
  • Career-Linked Recognition & Rewards Compensation tends to track niche skills and client demand, leading to more favorable pay for specialized technical roles and markets. This structure helps some cohorts perceive their pay as market‑competitive.
  • Wellbeing & Lifestyle Benefits Offerings include access to mental‑health therapy sessions and gym membership or reimbursement. These additions complement core coverage in some roles.

Collabera Insights

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The Company
HQ: Basking Ridge, New Jersey
6,138 Employees
Year Founded: 1996

What We Do

In our relentless pursuit of greatness, we are dedicated to developing individuals, creating exceptional teams, and cultivating a unique culture of unity and care. As providers of digital talent solutions, we aim to positively impact businesses and communities globally. We would be honored to be your trusted and uncommon partner on this journey.

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