Talent.com
Careers Integrated Resources Inc
Compliance SpecialistCareers Integrated Resources Inc • Louisville, CO, United States
Compliance Specialist

Compliance Specialist

Careers Integrated Resources Inc • Louisville, CO, United States
30+ days ago
Job type
  • Full-time
Job description

Compliance Specialist

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Title: Compliance Specialist

Location: Louisville, CO Duration: 6+ months (possibility of extension) ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • This individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Healthcare products.
  • The Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations.
  • Duties also include compliance tracking, trend analysis and reporting to Management.
  • This individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.

JOB QUALIFICATIONS:

  • Evaluates incoming complaint information and maintains it in the electronic database.
  • Determines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
  • Works closely with customers and sales representatives to respond to complaint reports.
  • Closely monitors quality, completeness and timeliness of complaint investigations and files.
  • Reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.
  • Works with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.
  • Participates in team decision making and displays team problem solving/communication skills.
  • Prepares and presents information in meetings and to upper Management
  • May serve a team member on projects/programs.
  • May provide guidance and training to support staff and new analysts.
  • May visit customer sites to meet with staff to discuss complaint issues.
  • May take lead on specific complaint issues and coordinate with other departments to further investigate.
  • May create/ or be responsible for revision of procedures/processes
  • Ad hoc reporting.
  • Complies with all health, safety and environmental policies.

PREFERRED SKILLS/QUALIFICATIONS :

Regulatory and Quality Management skills

SKILLS/COMPETENCIES :

  • Customer service, Data analysis; Basic understandings of industry practices and standards; Other Skills: MS Office, Written and verbal communication;

EDUCATION:

  • BS in clinical/medical, Engineering or science

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

  • Reports to Senior Analyst/Supervisor/Manager position as applicable.
  • Works closely with other local QA, International RA/QA, Sales, Marketing, Customer Service, R&D, Manufacturing, Engineering, Clinicals and Legal departments.

WORKING ENVIRONMENT/PHYSICAL ACTIVITIES :

  • Usual Office environment with frequent Sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional Climbing.
  • Frequent use of eye, hand and finger coordination enabling use of Office machinery.
  • Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
  • Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.
  • *Occasional: Activity exists less than 1/3 of the time.
  • Frequent: Activity exists between 1/3 and 2/3 of the time.
Create a job alert for this search

Compliance Specialist • Louisville, CO, United States

Similar jobs

Loss Prevention Specialist

Arc Thrift StoresDenver, CO, United States
Full-time

Corporate - Lakewood, CO 80228.The Loss Prevention Specialist has responsibility to protect company assets and improve profitability by developing and implementing security and safety programs for ... Show more

 • Promoted

Healthcare Quality & Compliance Director

First OnsiteEnglewood, CO, United States
Temporary

Healthcare Quality & Compliance Director.As a Healthcare Quality and Compliance Director, your day is centered on ensuring the highest standards of patient care, safety, and regulatory compliance a... Show more

 • Promoted

Compliance Manager

Mondadori Digital S.p.A.Denver, CO, United States
Full-time

Jewish Family Service Of Colorado.This highly collaborative position plans, manages, and coordinates compliance activities at JFS to ensure adherence to ethical or regulatory standards.Monitors and... Show more

 • Promoted

Operations Compliance Specialist

Precision Resources Company, Inc.Englewood, CO, United States
Full-time

Operations Compliance Specialist.Qualifications You Must Have: Relevant experience can be considered as a substitute for the required educational qualifications.In the absence of a degree, a minimu... Show more

 • Promoted

Compliance Manager

Air Methods CorporationEnglewood, CO, United States
Full-time

The Compliance Manager oversees United Rotorcraft's (UR) defense and regulatory compliance initiatives, ensuring adherence to federal standards such as CMMC, DFARS, NIST 800-171, ITAR, and EAR.This... Show more

 • Promoted

Trust Compliance Administrator

Columbia BankDenver, CO, United States
Full-time

Trust Compliance Administrator.The Trust Compliance Administrator serves as a First Line of Defense risk and compliance partner responsible for supporting consistent risk, control, and compliance p... Show more

 • Promoted

Documentation Risk Specialist II

BOK FinancialDenver, CO, United States
Full-time

Documentation Risk Specialist II.We're building a culture at BOK Financial where amazing people can bring their best, be their best and work for the best.You've come to the right place to grow your... Show more

 • Promoted

Senior Regulatory Compliance Analyst

Blue Prism GroupDenver, CO, United States
Full-time

Senior Regulatory Compliance Analyst.SS&C combines proprietary technology with deep industry expertise to support complex financial and health care operations.Our teams design, implement, and opera... Show more

 • Promoted

Specialist, Risk and Compliance Services (PC)

DeloitteDenver, CO, United States
Full-time

Position Summary Join Deloitte's Risk & Brand Protection organization as a Specialist, Risk and Compliance Services, where you will support independence and conflicts processes that help protect o... Show more

 • Promoted

Sr Auditor, Corp Compliance

Fox Point RecruitmentDenver, CO, United States
Full-time

Hybrid in office in Denver, CO or Federal Way, WA Tuesdays and Wednesdays.The Senior Auditor of Compliance is a self-motivated, adaptive, quick learner who can manage and prioritize an evolving wor... Show more

 • Promoted

ASSET PROTECTION SPECIALIST

Kroger Family of CompaniesDenver, CO, United States
Full-time

Protect company assets through the execution of safety initiatives, inventory recovery and internal and external theft reduction programs.Assist with reduction of lost inventory, time, and assets, ... Show more

 • Promoted

DEN Quality Assurance & Compliance Specialist

CovenantDenver, CO, US
$26.00 hourly
Permanent

Covenant Aviation Security (CAS) is seeking a Quality Assurance & Compliance Specialist to support aviation security operations at Denver International Airport (DEN).The Quality Assurance & Complia... Show more

 • Promoted

Senior Global Energy & Infrastructure Counsel

Micron TechnologyLongmont, CO, United States
Full-time

Micron Technology is seeking a legal professional specializing in energy procurement to support its global operations.The ideal candidate will have 8–12+ years of legal experience, particularly in ... Show more

 • Promoted

Compliance Risk Analyst II

Westerra Credit UnionDenver, CO, United States
Full-time

At Westerra Credit Union, we believe You Can Do Money.It is a mindset that shapes how we empower each other and our members to take control, grow, and thrive financially.Our culture is built on bel... Show more

 • Promoted

Compliance Specialist

Careers Integrated Resources IncLouisville, CO, United States
Full-time

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.IRI has built its reputation on excellent service and integ... Show more

 • Promoted

Trade Compliance Manager

StandardAeroBroomfield, CO, United States
Full-time

Build an Aviation Career You're Proud Of.At StandardAero, we use our ingenuity and know-how to find solutions for the simple to the most complex challenges in aviation.Together, we get the job done... Show more

 • Promoted

Compliance Manager

SpectralinkLouisville, CO, United States
Full-time

DescriptionCompliance ManagerAbout Spectralink:At Spectralink, we empower mobile workforces with purpose-built communication solutions designed for critical industries such as healthcare, manufactu... Show more

 • Promoted

Compliance Manager

Global Medical Response IncEnglewood, CO, United States
Full-time

Compliance ManagerGreenwood Village, CO.HybridSalary Range $120K-$130K RangeWhy Choose GMR?Global Medical Response(GMR) and its family of solutions are dedicated to delivering compassionate, qualit... Show more

 • Promoted

Client Solutions Manager

Slice Merchant ServicesLoveland, CO, US
Full-time

Excellent opportunity to join a leading, national credit card processing company that has over a decade of industry experience.Slice Merchant Services offers innovative payment processing solutions... Show more

 • Promoted

Compliance Process Architect - Healthcare Technology SDLC

OracleDenver, CO, United States
Full-time

Job Description** In Oracle Health, we are at the intersection of healthcare and IT to deliver pioneering products and services that shape the way healthcare is provided.Our best-in-class technolo... Show more