Regulatory Affairs Specialist jobs in Fort Lauderdale, 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 Manager
- Open Scientific
-
Plantation, FL
FULL_TIME
- Company DescriptionHeadquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.This is a great step for someone who has progressed to a Manager level and wants to progress into a Director role in the future. If you are looking to take on a challenging role within a rapidly growing division that provides an A environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door. Job Description-Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)-Develop Design Dossiers and Technical Files for CE marking purposes-Develop other international regulatory submissions as required-Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.-Review, edit and provide regulatory and quality system approval for project documentation.-Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.-Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.-Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.-Develop procedures to ensure regulatory compliance-Act as an active regulatory representative on project teams -Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.-Review and provide regulatory authorization for Nonconformance reports (NCR)-Provide Regulatory Affairs support during internal and external audits.-Prepare and file facility registration documents-Conduct external audit activities as requested-Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA-Manage commercial device tracking-Develop clinical protocols and clinical study reports-Prepare and submit medical device reports -Perform various other duties as assignedQualifications-Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).-Solid knowledge of US and European regulatory processes, including Class III is required.-Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.-Experience interacting with U.S. FDA and European Notified Bodies is required.-Experience presenting at FDA meetings is preferred.-Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required. -Experience in review and approval of promotional review process strongly preferred-Comprehensive Knowledge of Design Control processes and controls-Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.Please send suitable resumes in confidence to JPCuadra @ openscientific.comAdditional InformationAll your information will be kept confidential according to EEO guidelines.
- 1 Month Ago
Community Affairs Specialist-External Affairs-FT BHC
- Broward Health
-
Fort Lauderdale, FL
FULL_TIME
- Broward Health Corporate SpectrumFTE: 1.000000Summary:Develops and manages an organization's relationships with various stakeholders in the community. Collaborates with community groups, nonprofits, a...
- 1 Month Ago
Permit Specialist
- Home Specialist MV LLC
-
Fort Lauderdale, FL
FULL_TIME
- Company: Energy Efficient Impact Windows and Doors-Established Home Improvement Company focused on energy-efficient Impact Windows and Doors. Position: Permitting Specialist Required Skills:•Permit Ap...
- 5 Days Ago
Community Relations Specialist-External Affairs-FT BHC #2285
- Broward Health
-
Fort Lauderdale, FL
FULL_TIME
- Broward Health Corporate SpectrumFTE: 1.000000Summary:Develops and manages an organization's relationships with various stakeholders in the community. Collaborates with community groups, nonprofits, a...
- 7 Days Ago
Experienced or Licensed Veterinary Technician - Hollywood, FL
- Broward Veterinary Specialist
-
Hollywood, FL
FULL_TIME
- Who we are: Broward Veterinary Specialists is ready to hire a small animal internal medicine/oncology technician to join our dedicated team. This is a full-time position, 4 days per week (Monday throu...
- 10 Days Ago
General Laborer
- Cable Wiring Specialist
-
Hollywood, FL
FULL_TIME
- Cable Wiring Specialist, Inc. provides a large suite of construction and engineering services to the Telecommunications and Fiber Optic industry. With a large workforce located throughout Florida and ...
- 14 Days Ago
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0 Regulatory Affairs Specialist jobs found in Fort Lauderdale, FL area
Senior Regulatory Affairs Specialist
- DemeTECH Corporation
-
Miami Lakes, FL
- DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal...
- 4/18/2024 12:00:00 AM
Financial Consultant - Fort Lauderdale, FL
- Fidelity TalentSource LLC
-
Fort Lauderdale, FL
- Job Description: Financial Consultant If you no longer want to spend your time on sourcing new clients and would rather ...
- 4/18/2024 12:00:00 AM
Product Developer
- Hiring Now!
-
Miami, FL
- As the Product Developer, you are accountable for the development for products sold by the business and supporting rapid...
- 4/17/2024 12:00:00 AM
Category Manager
Specialty Meats, Sausages & Produce
- Hiring Now!
-
Miami, FL
- As the Category Manager, you are accountable for the development for products sold by the business and supporting rapid ...
- 4/17/2024 12:00:00 AM
Treasury Director
- Confidential
-
Fort Lauderdale, FL
- Job Summary: We are seeking a dynamic and experienced Treasury Director to join our finance team. Reporting directly to ...
- 4/16/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Demetech Corporation
-
Hialeah, FL
- DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal...
- 4/16/2024 12:00:00 AM
Treasury Director
- Confidential
-
Fort Lauderdale, FL
- Job Summary: We are seeking a dynamic and experienced Treasury Director to join our finance team. Reporting directly to ...
- 4/16/2024 12:00:00 AM
Financial Representative - Fort Lauderdale, FL
- Fidelity TalentSource LLC
-
Fort Lauderdale, FL
- Job Description: Financial Representative We believe that as a Financial Representative, you make a key impact on the br...
- 4/16/2024 12:00:00 AM
About Fort Lauderdale, Florida
Fort Lauderdale (/ˈlɔːdərdeɪl/) is a city in the U.S. state of Florida, 28 miles (45 km) north of Miami. It is the county seat of Broward County. As of the 2017[update] census, the city has an estimated population of 180,072. Fort Lauderdale is a principal city of the Miami metropolitan area, which was home to an estimated 6,158,824 people in 2017.
The city is a popular tourist destination, with an average year-round temperature of 75.5 °F (24.2 °C) and 3,000 hours of sunshine per year. Greater Fort Lauderdale, encompassing all of Broward County, hosted 12 million visitors in 2012, including...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,372 to $98,330
Fort Lauderdale, Florida area prices
were up 2.9% from a year ago
were up 2.9% 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