Regulatory Affairs Specialist jobs in Tampa, FL

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)

K
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.

  • 20 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Lakeland, FL FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Tampa, FL FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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VP, Risk Regulatory Affairs - C13 (Hybrid)
  • Hispanic Technology Executive Council
  • Tampa, FL FULL_TIME
  • The Risk Regulatory Affairs team ensures the Independent Risk organization maintains a strong and productive engagement model with Regulators, Prudential Regulators including the Federal Reserve, OCC,...
  • 1 Month Ago

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VP - Strategy & Reporting, Risk Regulatory Affairs - Hybrid
  • Hispanic Technology Executive Council
  • Tampa, FL FULL_TIME
  • The Risk Regulatory Affairs team ensures the Independent Risk organization maintains a strong and productive engagement model with Regulators, predominantly Prudential Regulators including the Federal...
  • 1 Month Ago

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Regulatory Specialist I
  • Moffitt Cancer Center Careers
  • Tampa, FL FULL_TIME
  • At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over ...
  • 13 Days Ago

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0 Regulatory Affairs Specialist jobs found in Tampa, FL area

K
Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

I
Vice President of Finance and Accounting
  • Integro Professional Services, LLC
  • Tampa, FL
  • Location: Central Florida (Corporate Office), with locations in the Southeast United States Salary Range: $150,000 to $3...
  • 3/27/2024 12:00:00 AM

M
Tax Withholding & Reporting - Tax Operations, AVP
  • MUFG Bank, Ltd.
  • Tampa, FL
  • Do you want your voice heard and your actions to count? Discover your opportunity with Mitsubishi UFJ Financial Group (M...
  • 3/27/2024 12:00:00 AM

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Personal Banker Boot Ranch
  • WELLS FARGO BANK
  • Palm Harbor, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Personal Banker 66th Street
  • WELLS FARGO BANK
  • Saint Petersburg, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Branch Manager - Downtown St Pete
  • WELLS FARGO BANK
  • Saint Petersburg, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/26/2024 12:00:00 AM

C
Vice President / Audit Manager - IA Finance COO and Change (Hybrid)
  • Citigroup, Inc.
  • Tampa, FL
  • The Audit Manager is an intermediate level role responsible for managing a team that is performing complex and critical ...
  • 3/25/2024 12:00:00 AM

O
Finance Coordinator
  • Open Aid Alliance
  • Saint Petersburg, FL
  • Open Aid Alliance is seeking a dedicated and self-directed Finance Coordinator to join our team. The ideal candidate wil...
  • 3/24/2024 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 Affairs Specialist jobs
$72,050 to $96,558
Tampa, Florida area prices
were up 1.1% from a year ago

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