Regulatory Relations Specialist jobs in Brandon, FL

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL FULL_TIME
  • Responsibilities:

    Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.

    Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.

    Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.

    Evaluate risk of proposed regulatory strategies; may offer solutions.

    Reviews proposed labeling for compliance with applicable US and international regulations.

    Writes/manages the development of package inserts.

    Reviews and evaluates promotion and advertising material for compliance with applicable regulations.

    Reviews proposed product changes for impact on regulatory status of the product.

    Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.

    Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.

    Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.

    Expected Areas of Competence

    Demonstrated strong writing and communication skills.

    Strong attention to detail, ability to multi-task

    Knowledge of overall business environment, the orthopedic industry, and the marketplace

    Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products.

    Ability to function well as a member of the team and build relationships between RA and other areas of the organization.

    Able to identify risk in Regulatory strategies.

    Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred.

    Basic computer skills, including Microsoft Office Suite

    Requirements:

    US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent).

    A minimum of 3 years' experience in Regulatory Affairs

    Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred.

    Regulatory Affairs Certification (US or EU) preferred.

    A combination of education and experience may be considered.

  • 19 Days Ago

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Regulatory Reporting Specialist/Project Manager
  • Axelon Services Corporation
  • Tampa, FL CONTRACTOR,FULL_TIME
  • Global Financial Firm located in Tampa, FL has an immediate contract opportunity for an experienced Regulatory Reporting Specialist/Project Manager "This role is currently on a Hybrid Schedule. You wi...
  • 6 Days Ago

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Public Relations Specialist
  • Lukos
  • Tampa, FL FULL_TIME
  • Public Relations Specialist Minimum Qualifications Summary Certification & Education MA/MS required Experience Required Minimum 10 years experience required Job Objective The Public Relations Speciali...
  • 1 Day Ago

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Client Relations Specialist
  • MattLaw
  • Tampa, FL FULL_TIME
  • Benefits: 401(k) 401(k) matching Competitive salary Health insurance Paid time off To learn more from our founder and Managing Partner about MattLaw® and the next steps in applying for this position, ...
  • 4 Days Ago

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Physician Relations Specialist
  • AdventHealth Tampa
  • Tampa, FL FULL_TIME
  • Description All the benefits and perks you need for you and your family: Benefits from Day One Paid Days Off from Day One Student Loan Repayment Program Career Development Our promise to you: Joining ...
  • 8 Days Ago

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Mediator | Workforce Relations Specialist
  • ProSidian Consulting, LLC
  • Lakeland, FL FULL_TIME
  • Company DescriptionProSidian is a Management and Operations Consulting Firm focusing on providing value to clients through tailored solutions based on industry-leading practices. We help forward-think...
  • 1 Month Ago

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0 Regulatory Relations Specialist jobs found in Brandon, FL area

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Natural Resources Senior Ecologist / Senior Project Manager
  • ECS Ltd
  • Tampa, FL
  • What You'll Do Conducting and managing wetland and natural resource projects Being intimately familiar with Federal [USA...
  • 4/23/2024 12:00:00 AM

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EHS Compliance Project Manager
  • GHD Group
  • Tampa, FL
  • Job Description There's no pledge more important than the one we make to look after our environment, and we're committed...
  • 4/23/2024 12:00:00 AM

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Medical Lab Technician
  • HCA Florida Brandon Hospital
  • Brandon, FL
  • Description Introduction Are you looking for a work environment where diversity and inclusion thrive? Submit your applic...
  • 4/21/2024 12:00:00 AM

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Materials Management Coordinator 1
  • LifeLink
  • Tampa, FL
  • We Are LifeLink... Our Vision is to maximize the gift of life while giving hope to donor families and transplant patient...
  • 4/21/2024 12:00:00 AM

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Medical Equipment Service and Delivery Driver (Wednesday - Sunday)
  • Agiliti Health, Inc.
  • Tampa, FL
  • Job Description: Who We Are Agiliti is a nationwide company of passionate medical equipment management experts who belie...
  • 4/21/2024 12:00:00 AM

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Concrete Leadman
  • BrightView Landscapes, LLC
  • Seffner, FL
  • Description Looking for an opportunity where success comes naturally? Then you may have found your crew. Were looking fo...
  • 4/20/2024 12:00:00 AM

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Metrics Reporting Analyst
  • Software Guidance and Assistance, Inc.
  • Tampa, FL
  • Software Guidance & Assistance, Inc., (SGA), is searching for a Metrics Reporting Analyst for a CONTRACT assignment with...
  • 4/20/2024 12:00:00 AM

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Medical Lab Technician
  • HCA Florida Brandon Hospital
  • Brandon, FL
  • Description Introduction Are you looking for a work environment where diversity and inclusion thrive? Submit your applic...
  • 4/19/2024 12:00:00 AM

Brandon is an unincorporated community and census-designated place (CDP) in Hillsborough County, Florida, United States. It is part of the Tampa–St. Petersburg–Clearwater Metropolitan Statistical Area. As of the 2010 census, the CDP had a population of 103,483, up from 77,895 at the 2000 census. Brandon's census boundaries include Palm River-Clair Mel to the west across U.S. Route 301, Valrico to the east, Riverview and Bloomingdale to the south, and East Lake-Orient Park, Mango, and Seffner to the north. Brandon is 11 miles (18 km) east of downtown Tampa and 14 miles (23 km) southwest of Plan...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$70,370 to $96,606
Brandon, Florida area prices
were up 1.1% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020