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Collabera

MDR/Vigilance Specialist

Moundsview, 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 ...

Collabera

Vigilance Specialists

Minneapolis, MN

Associate MDR/Vigilance Specialists are responsible for theintake, documentation, Medical Device Reporting, and investigation of complaintsfor legacy Neuromodulation products in accordance with ...

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Vigilance Specialist information

What is a vigilance specialist?

Vigilance Specialists are professionals responsible for monitoring, detecting, and investigating potential fraud, corruption, or misconduct within an organization, particularly in government or public sector entities. They ensure compliance with ethical standards, regulations, and policies to promote transparency and integrity. Their duties may include conducting audits, reviewing processes, and recommending corrective actions to prevent future violations. Vigilance Specialists often work closely with law enforcement and regulatory agencies to resolve cases of unethical behavior.

What are the key skills and qualifications needed to thrive as a vigilance specialist, and why are they important?

To thrive as a Vigilance Specialist, you need strong analytical skills, attention to detail, and a background in compliance, risk management, or law, often supported by relevant degrees or certifications. Familiarity with regulatory reporting systems, data analysis tools, and case management software is typically required. Outstanding communication, integrity, and problem-solving abilities help you stand out in this role. These skills are crucial for identifying compliance risks, ensuring regulatory adherence, and protecting organizational integrity.

What are some typical challenges faced by a vigilance specialist, and how can they be addressed?

Vigilance Specialists often encounter challenges such as managing large volumes of data, staying updated with regulatory changes, and ensuring timely reporting of compliance issues. To address these, it's important to develop strong organizational skills, maintain effective communication with cross-functional teams, and participate in continuous training on regulatory updates. Collaborating closely with other departments, such as legal and compliance, also helps in identifying and mitigating potential risks more efficiently, making the role both dynamic and rewarding.

What is the future of vigilance specialist jobs?

Vigilance specialist jobs are expected to grow as companies and regulatory agencies increase focus on compliance, risk management, and fraud detection. The role often requires knowledge of data analysis, monitoring tools, and industry regulations, with opportunities expanding in sectors like pharmaceuticals, finance, and manufacturing.
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Vigilance Specialist jobs near you
Infographic showing various Vigilance Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution.

VIGILANCE SPECIALIST

Integrated Resources INC

Moundsview, MN • On-site

Full-time

Medical, Life

Re-posted 25 days ago

Job description

Company Description

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 Description

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

Qualifications

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.

Additional Information

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



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About Integrated Resources

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.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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