-
Regulatory Compliance Specialist
2 weeks ago
Irvine Ranch Water District Irvine, United StatesGeneral Description · Irvine Ranch Water District is currently accepting applications for a Regulatory Compliance Specialistin our Regulatory Compliance Department. · The District · Irvine Ranch Water District (IRWD) is a progressive, values-driven agency, with an international r ...
-
SR. Compliance Specialist
4 weeks ago
Insight Global Irvine, United StatesInsight Global is looking for a Sr. Compliance Specialist to work for one of our aerospace clients based in California. The Sr. Compliance Specialist, Export and Import works in the International Trade Compliance Department ("ITCD") to provide comprehensive and proactive export c ...
-
Regulatory Compliance Specialist
4 weeks ago
Irvine Ranch Water District Irvine, United StatesSalary : $81, $115,835.20 Annually · Location : Irvine, CA · Job Type: Full-Time Regular · Job Number: 00792 · Department: Regulatory Compliance · Opening Date: 05/01/2024 · Closing Date: 5/26/2024 11:59 PM Pacific · General Description · Irvine Ranch Water District is cur ...
-
SeniorQuality Compliance Specialist
3 weeks ago
JobRialto Irvine, United StatesSummary:The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriateKey Responsibilities:Manage customer relationships and expectations during the co ...
-
Quality Assurance Compliance Specialist
5 days ago
Compunnel Inc. Irvine, United StatesJob Description: · Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. · Execute complaint investigations multifunctional approac ...
-
Compliance Specialist
2 weeks ago
Össur Irvine, United StatesBasic Function: · The Compliance Specialist is responsible for assisting the management of the compliance program for the Össur Americas Business Units. This role is responsible for management of compliance functions that ensure that the organization follows state and federal reg ...
-
Export Compliance Specialist
3 weeks ago
Leonid Group Ltd Irvine, United StatesThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions. · Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast c ...
-
Trade Compliance Specialist
2 weeks ago
Supernal Irvine, United StatesSupernal is at the forefront of creating emerging mobility solutions that will foster the development of human-centered cities. We are designing a completely new electric vertical take-off and landing (eVTOL) aircraft tailored to the mobility needs of future cities. This allows p ...
-
Export Compliance Specialist
2 weeks ago
Leonid Group Ltd Irvine, United StatesThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions. · Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast ...
-
Senior Compliance Specialist
3 weeks ago
The Capital Group Companies , Inc. Irvine, United States"I can succeed as a Senior Compliance Specialist at Capital Group." · As a Senior Compliance Specialist on our Client Services team, you will oversee and help negotiate contracts and provide compliance support for a number of Capital Group's investment offerings and services. Wea ...
-
Senior Compliance Specialist
3 weeks ago
The Capital Group Companies , Inc. Irvine, United States'I can succeed as a Senior Compliance Specialist at Capital Group.'As a Senior Compliance Specialist on our Client Services team, you will oversee and help negotiate contracts and provide compliance support for a number of Capital Group's investment offerings and services. Wearin ...
-
Compliance Specialist
2 weeks ago
MemorialCare Health System Fountain Valley, United StatesTitle: Compliance Specialist · Location: Fountain Valley, CA · Department: Hospital Administration · Status: Full-Time · Shift: Days (8hr) · Pay Range*: $27.26/hr - $39.52/hr · At MemorialCare Health System, we believe in providing extraordinary healthcare to our communities and ...
-
SeniorQuality Compliance Specialist
4 weeks ago
JobRialto Irvine, United States· Summary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer relationships and expectation ...
-
Compliance Specialist
1 week ago
Solari Enterprises Orange, United StatesPosition Overview: · We currently have a Compliance Specialist position available in Orange, CA The position is an exempt level role that requires the use of independent judgment and decision-making skills as well as educational expertise to maintain compliance of the regulatory ...
-
Quality Compliance Specialist
2 weeks ago
JobRialto Irvine, United States· Summary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer relationships and expectation ...
-
Quality Compliance Specialist
2 weeks ago
Trinus Irvine, United StatesJob Description · Job DescriptionSummary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer re ...
-
Legal Compliance Specialist
2 weeks ago
Össur Irvine, United StatesThe Compliance Specialist is responsible for assisting the management of the compliance program for the Össur Americas Business Units. This role is responsible for management of compliance functions that ensure that the organization follows state and federal regulations including ...
-
Compliance Specialist
2 days ago
HB Staffing Huntington Beach, United StatesPosition: Compliance SpecialistLocation: Huntington Beach, CAPay: $23/hrExperience: 1 to 3 years of Medicare Audit or Compliance experience requiredEducation: Associate's or bachelors degree in healthcare or equivalent preferredType: Full-time; ContractSchedule: Monday - Friday, ...
-
Labor Compliance Specialist
2 weeks ago
Primoris Services Corporation Lake Forest, United StatesJob Description · Job DescriptionJob Summary: · Primoris Services Corporation is currently searching for a Labor Compliance Specialist in the Lake Forest, CA area. This position will support the Corporate Labor Compliance Team in delivering project documents related to Unions, Ce ...
-
Compliance Specialist
4 weeks ago
Western National Group, Inc. Chino, United StatesDon't make me use my Tax Compliance Specialist voice You will love working at Western Why? Because we make a difference in the lives of others. What we do is really important and while we're at it, we know you'll have fun, you'll be rewarded, and y Compliance Specialist, Complian ...
SeniorQuality Compliance Specialist - Irvine, United States - JobRialto
Description
Summary:
The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
Key Responsibilities:
Manage customer relationships and expectations during the course of complaint investigation and resolution process
Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.
Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
Additional Skills:
Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
Proven expertise in MS Office Suite and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving, critical thinking, and investigative skills
Full knowledge and understanding of Client policies, procedures, and guidelines relevant to quality compliance
Good knowledge of medical terms and human anatomy
Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently on complex work and reviewed for accuracy and soundness
Education and Experience:
Bachelor's Degree or equivalent in related field
5-7 years of experience required
Education:
Bachelors Degree
#J-18808-Ljbffr