Regulatory Relations Specialist jobs in Tampa, 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.

  • 15 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...
  • 3 Days 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, ...
  • 1 Day 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 ...
  • 5 Days Ago

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Donor Relations Specialist
  • Gulfside Healthcare Services
  • Land O' Lakes, FL FULL_TIME
  • Benefits: 401(k) 401(k) matching Competitive salary Dental insurance Donation matching Employee discounts Free food & snacks Health insurance Paid time off Parental leave Training & development Tuitio...
  • 1 Month 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 Tampa, FL area

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Credit Review Senior Officer I -Hybrid- C14 - TAMPA
  • Citigroup
  • Tampa, FL
  • The Credit Review Senior Manager is a strategic professional who closely follows latest trends in own field and adapts t...
  • 4/19/2024 12:00:00 AM

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Audit Manager - IA Quality Assurance (Compliance)
  • Citigroup
  • Tampa, FL
  • Citi's Internal Audit (IA) division provides independent assessments of the company's governance, risk management and in...
  • 4/19/2024 12:00:00 AM

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Manager, Director, Liquidity Risk
  • KPMG
  • Tampa, FL
  • Business Title: Manager, Director, Liquidity Risk Requisition Number: 111337 - 27 Function: Advisory Area of Interest: S...
  • 4/19/2024 12:00:00 AM

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Treasury/Liquidity Sr Analyst - C13/VP
  • Citigroup
  • Tampa, FL
  • **Overview:** The individual will work in the Liquidity Management (LM) team within Citi Treasury Global Function. The t...
  • 4/19/2024 12:00:00 AM

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Compliance Manager - Incident Response
  • Elevance Health
  • Tampa, FL
  • WARNING: Please beware of phishing scams that solicit interviews or promote work-at-home opportunities, some of which ma...
  • 4/19/2024 12:00:00 AM

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Systems Expert
  • CAE USA INC
  • Tampa, FL
  • Role and Responsibilities Summary The Systems Expert is proficient in all aspects of design, analysis, implementation an...
  • 4/19/2024 12:00:00 AM

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Veterinarian Technician II
  • Charles River Laboratories
  • La Belle, FL
  • Under the direction of veterinary staff, maintain and monitor the health and physical environment of Charles River or ex...
  • 4/18/2024 12:00:00 AM

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Lead Electrical Engineer - Substation Design and Power Electronics (STATCOM/FACTS/HVDC) - US Hybrid
  • Black & Veatch
  • Tampa, FL
  • **Lead Electrical Engineer - Substation Design and Power Electronics (STATCOM/FACTS/HVDC) - US Hybrid** Date: Apr 8, 202...
  • 4/18/2024 12:00:00 AM

Tampa is a major city in, and the county seat of, Hillsborough County, Florida, United States. It is on the west coast of Florida on Tampa Bay, near the Gulf of Mexico, and is the largest city in the Tampa Bay Area. The bay's port is the largest in the state, near downtown's Channel District. Bayshore Boulevard runs along the bay, and is east of the historic Hyde Park neighborhood. Today, Tampa is part of the metropolitan area most commonly referred to as the "Tampa Bay Area". For U.S. Census purposes, Tampa is part of the Tampa-St. Petersburg-Clearwater, Florida Metropolitan Statistical Area....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$70,370 to $96,606
Tampa, 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