Regulatory Affairs Specialist jobs in Brandon, 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)
Recently Added Regulatory Affairs Specialist jobs
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.
- 22 Days Ago
Sr. Manager, Regulatory Affairs
- Axogen
-
Tampa, FL
FULL_TIME
- Axogen is hiring for a Sr. Manager of Regulatory in Tampa, FL, Alachua, FL, or Vandalia, OH! Job Summary of the Sr. Manager of Regulatory The Sr. Manager, Regulatory will provide direction and leaders...
- 18 Days Ago
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,...
- 20 Days Ago
SVP, Risk Regulatory Affairs Lead – Model Risk Management - C14
- Citi
-
TAMPA, FL
OTHER
- The objective of this role is to drive the execution of regulatory interactions across Risk Management, to ensure the organization is responsive, agile and well-prepared for unique and demanding regul...
- Just Posted
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...
- 9 Days Ago
Fiber Technician
- Cable Wiring Specialist
-
Lakeland, FL
FULL_TIME
- Cable Wiring Specialist, Inc. (CWSI) provides a large suite of construction and engineering services to the cable and Fiber Optic communications industry. With a large workforce and fleet located thro...
- 21 Days Ago
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0 Regulatory Affairs Specialist jobs found in Brandon, FL area
Vice President Finance Reporting - Lead Analyst
- Citigroup
-
Tampa, FL
- The Lead Analyst position is an integral member of the Global Regulatory Reporting (GRR). This is a high-profile functio...
- 4/26/2024 12:00:00 AM
ICM Data Analyst, Assistant Vice President (C-12)
- Citigroup, Inc.
-
Tampa, FL
- The Business Analytics Sr Analyst is a seasoned professional role. Applies in-depth disciplinary knowledge, contributing...
- 4/26/2024 12:00:00 AM
Counter Threat Finance Analyst
- Cambridge International Systems Inc
-
Tampa, FL
- When you join the Cambridge team, you are part of a skilled and talented global community that is united by a set of cor...
- 4/26/2024 12:00:00 AM
Operational Risk Analyst / Compliance Analyst ( LOCALS ONLY ) --- Remote & Twice a week Onsite
- Zillion Technologies, Inc.
-
Tampa, FL
- THIS IS A DIRECT BANKING CLIENT REQUIREMENT ! Those authorized to work without sponsorship are encouraged to apply pleas...
- 4/26/2024 12:00:00 AM
Operational Risk Sr Manager - Vice President
- Citigroup, Inc.
-
Tampa, FL
- The Operational Risk Sr Manager accomplishes results through the management of professional team(s) and department(s). I...
- 4/25/2024 12:00:00 AM
Database Security Engineer, Assistant Vice President
- 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...
- 4/23/2024 12:00:00 AM
Senior Audit Manager - IA Treasury
- Citigroup, Inc.
-
Tampa, FL
- The Senior Audit Manager is a senior level management position responsible for managing a complex and critical unit with...
- 4/22/2024 12:00:00 AM
VP, AML Compliance Officer - Risk and Control (Hybrid)
- Citigroup, Inc.
-
Tampa, FL
- The VP, AML Compliance Officer is responsible for oversight and the execution of the Management Control Assessment (MCA)...
- 4/22/2024 12:00:00 AM
About Brandon, Florida
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 Affairs Specialist jobs
$72,005 to $96,497
Brandon, Florida area prices
were up 1.1% from a year ago
were up 1.1% from a year ago
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