Regulatory Affairs Specialist jobs in Florida
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.
- 21 Days Ago
Regulatory Affairs Specialist
- Confidential
-
Boca Raton, FL
FULL_TIME
- The Company is a small public company based in Boca Raton, operating in two divisions. Medical Devices: Surgical device marketed in the US, Europe and a range of other countries internationally. The d...
- 1 Month Ago
Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
- OneSource Regulatory
-
REMOTE, FL
FULL_TIME|PART_TIME
- Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
- 1 Month 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...
- 17 Days Ago
Manager, Regulatory Affairs
- ADMA BIOMANUFACTURING LLC
-
Boca Raton, FL
OTHER
- Job Details Level: Management Job Location: ADMA Biologics - Boca Raton, FL Position Type: Full Time Education Level: 4 Year Degree Salary Range: Undisclosed Travel Percentage: None Job Shift: Day Des...
- 22 Days Ago
Senior Manager, Regulatory Affairs
- ADMA BIOMANUFACTURING LLC
-
Boca Raton, FL
OTHER
- Job Details Job Location: ADMA Biologics - Boca Raton, FL Salary Range: Undisclosed Job Shift: Day DescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior ...
- 24 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- DivIHN Integration Inc
-
Green Oaks, IL
- DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, C...
- 4/24/2024 12:00:00 AM
Regulatory Affairs Specialist
- Morair Medtech, LLC
-
Seattle, WA
- Morair Medtech, LLC is at the forefront of medical technology, specializing in endobronchial treatments for lung disease...
- 4/23/2024 12:00:00 AM
Regulatory Affairs Specialist
- Prokatchers Llc
-
Saint Louis, MO
- Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist
- Direct Recruiters Inc.
-
Chicago, IL
- Our client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Reg...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Lake Forest, IL
- Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
- 4/21/2024 12:00:00 AM
Regulatory Affairs Specialist
- ProKatchers LLC
-
St Louis, MO
- Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
- 4/20/2024 12:00:00 AM
Regulatory Affairs Specialist
- Integrated Resources, Inc ( IRI )
-
St Louis, MO
- Job Title: Regulatory Affairs Expert Job Location: St. Louis, MO- Hybrid Job Duration: 12 Months- Temp to perm possibili...
- 4/20/2024 12:00:00 AM
About Florida
Florida (/ˈflɒrɪdə/ (listen); Spanish for "land of flowers") is the southernmost contiguous state in the United States. The state is bordered to the west by the Gulf of Mexico, to the northwest by Alabama, to the north by Georgia, to the east by the Atlantic Ocean, and to the south by the Straits of Florida. Florida is the 22nd-most extensive (65,755 sq mi or 170,300 km2), the 3rd-most populous (21,312,211 inhabitants), and the 8th-most densely populated (384.3/sq mi or 148.4/km2) of the U.S. states. Jacksonville is the most populous municipality in the state and the largest city by area in th...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,156 to $96,701
Most Popular Cities in Florida for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019