Regulatory Affairs Specialist jobs in Knoxville, TN

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

Recently Added Regulatory Affairs Specialist jobs

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2153 - 284 - Regulatory Specialist
  • DeRoyal
  • Powell, TN FULL_TIME
  • 2153 - 284 - Regulatory Specialist   Regulatory Specialist Global medical device manufacturer, DeRoyal, has an immediate opening for an experienced Regulatory Affairs professional to join our Corporate Regulatory Affairs team!  The ideal candidate will be responsible for working with DeRoyal's Wound Care division by performing various duties to ensure and promote the efficient and productive functioning of the Regulatory Affairs team. Some responsibilities include: Helps to ensure the Company’s compliance to regulatory requirements for both domestic and international markets.   Evaluates new medical device products and suggests changes to existing products to assist design team in meeting any regulatory requirements. Initiates and completes appropriate steps/paperwork.   Develops and maintains pre-market approval documentation for new devices (510k, Technical Files) and modifications of existing devices.   Investigates product system complaints and, if necessary, creates and submits reports to regulatory agencies (FDA, Competent Authorities, etc.) within required time-frame.   Assists in the creation and maintenance of regulatory facility registrations, device listings and any other licenses or required regulatory documents for all divisions.   Researches and keeps abreast of domestic and international regulatory issues related to the industry such as new standards, revised regulations, etc. and keeps relevant departments informed.   Coordinates and assists with corrective actions taken regarding product/quality system deficiencies (Recall, Advisory Notices, etc.) and the relevant notifications to Regulatory authorities.   Participates and presents training information to new hires and other departments within the company.   Assists in the development of procedures and/or training materials for the Regulatory department.   Reviews labeling material for products to ensure compliance with regulatory requirements.   EDUCATION and/or EXPERIENCE: Bachelor’s degree and/or minimum 5 years relevant experience required. Must be knowledgeable with all applicable sections of the 21 CFR, 510(k) submissions, and MDR reporting and other domestic and international regulatory issues.   LANGUAGE SKILLS: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.   OTHER SKILLS and ABILITIES: Ability to use office copier and computer required.  Prior experience using Microsoft Word, Excel and PowerPoint preferred.  Demands ability to evaluate situations and plan appropriate actions.  Requires skill in dealing diplomatically and professionally with employees representing all levels of organization.  Requires excellent verbal and written communication skills as well as attention to detail and the ability to initiate and complete projects within required time-frames.  Must be able to work well under limited supervision.
  • 1 Month Ago
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Lawn Specialist
  • TruGreen - Lawn Specialist - Alcoa, TN
  • Fontana Dam, NC FULL_TIME
  • TruGreen is Hiring Residential Lawn Specialists Immediate Openings in Alcoa, TN At TruGreen, we are committed to our customers, our teams, our values, and the science of lawn care. A career with TruGr...
  • 29 Days Ago
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Specialist, Medical Office
  • TruGreen - Lawn Specialist - Alcoa, TN
  • Fontana Dam, NC FULL_TIME
  • Immediate Openings in Alcoa, TN At TruGreen, we are committed to our customers, our teams, our values, and the science of lawn care. 00 per hour Average income is $850 - $1,200 per week* - Based on ho...
  • 28 Days Ago
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Retail Merchandiser (PT)
  • Apollo Retail Specialist
  • Knoxville, TN PART_TIME
  • As a merchandiser, you’ll take on project-based work to ensure products and displays are visually appealing to attract and engage shoppers, build strong relationships with store managers, ensure the r...
  • 11 Days Ago
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Regulatory Coordinator
  • University of Tennessee Medical Center
  • Knoxville, TN FULL_TIME
  • Position Summary: Prepares, submits and maintains clinical trials regulatory data and documents. Initiates and maintains all Regulatory documents necessary for submission to Institutional Review Board...
  • 15 Days Ago
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Regulatory Compliance Officer
  • Apex Bank
  • Knoxville, TN FULL_TIME
  • Job Description Position Summary: We are seeking a Regulatory Compliance Manager to support the Bank’s audit and compliance team with development, implementation and maintenance of the Bank’s complian...
  • 12 Days Ago
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0 Regulatory Affairs Specialist jobs found in Knoxville, TN area

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Investment Consultant - Knoxville, TN
  • Fidelity TalentSource LLC
  • Knoxville, TN
  • Job Description: Investment Consultant You joined the financial services industry to make a difference in the lives of y...
  • 4/23/2024 12:00:00 AM
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Director of Portfolio Accounting
  • Mollenhour Gross
  • Knoxville, TN
  • Job Description Job Description We (Mollenhour Gross, LLC – “MG”) are actively recruiting a Director of Portfolio Accoun...
  • 4/23/2024 12:00:00 AM
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Financial Advisor
  • Hiring Now!
  • Knoxville, TN
  • The freedom and flexibility of an entrepreneur. Backed by our vast resources. It's the best of both worlds. While Edward...
  • 4/23/2024 12:00:00 AM
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Director of Portfolio Accounting
  • Mollenhour Gross
  • Knoxville, TN
  • Job Description Job Description We (Mollenhour Gross, LLC MG) are actively recruiting a Director of Portfolio Accounting...
  • 4/22/2024 12:00:00 AM
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Programs and Grants Manager, Tennessee Alliance
  • BOYS & GIRLS CLUBS OF THE TENNESSEE VALLEY
  • Knoxville, TN
  • Job Details Job Location Administrative Office - Knoxville, TN Position Type Full Time Education Level 4 Year Degree Sal...
  • 4/21/2024 12:00:00 AM
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Financial Advisor - career shift opportunity
  • Hiring Now!
  • Knoxville, TN
  • The freedom and flexibility of an entrepreneur. Backed by our vast resources. It's the best of both worlds. While Edward...
  • 4/21/2024 12:00:00 AM
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Financial Advisor - career shift opportunity
  • Edward Jones
  • Knoxville, TN
  • The freedom and flexibility of an entrepreneur. Backed by our vast resources. It's the best of both worlds. While Edward...
  • 3/26/2024 12:00:00 AM
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Financial Advisor - career shift opportunity
  • Edward Jones
  • Knoxville, TN
  • The freedom and flexibility of an entrepreneur. Backed by our vast resources. It's the best of both worlds. While Edward...
  • 3/18/2024 12:00:00 AM
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About Knoxville, Tennessee

Knoxville is a city in the U.S. state of Tennessee, and the county seat of Knox County. The city had an estimated population of 186,239 in 2016 and a population of 178,874 as of the 2010 census, making it the state's third largest city after Nashville and Memphis. Knoxville is the principal city of the Knoxville Metropolitan Statistical Area, which, in 2016, was 868,546, up 0.9 percent, or 7,377 people, from to 2015. The KMSA is, in turn, the central component of the Knoxville-Sevierville-La Follette Combined Statistical Area, which, in 2013, had a population of 1,096,961. First settled in 178...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$69,650 to $93,342
Knoxville, Tennessee area prices
were up 1.3% from a year ago
View detail

What does a Regulatory Affairs Specialist do?

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020