Top Regulatory Affairs Executive jobs in Pompano Beach, FL
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive 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
Project Executive
- Blue Ridge Executive Search
-
Fort Lauderdale, FL
FULL_TIME
- One of the top General Contractors in Fort Lauderdale is looking for a Project Executive. This potential candidate needs to have at least 10 years of experience as a Senior Project Manager or Project ...
- 1 Day Ago
Inside Food Sales Rep for a Japanese food company
- TOP NY
-
Miramar, FL
FULL_TIME
- Must have a strong interest in Japanese/ Asian food. Direct-Hire, Full-time position.Work Hour: 8am- 5pm (Including unpaid 1 hour break)1. Locating New Sales opportunities through cold-calling, attend...
- 24 Days Ago
House Cleaner - House Cleaning - Mon - Fri / FT & PT / $21-$28/hr + TIPS
- Executive Maids
-
Pompano Beach, FL
FULL_TIME
- About usWe are professional, supportive, rewarding and our goal is to Hire additional Cleaning Professionals to join our growing company. Executive Maids has been cleaning homes for over 30 years. We ...
- 1 Month Ago
Yacht Accountant
- Top Tier Reps LLC
-
Fort Lauderdale, FL
FULL_TIME
- Salary: $50,000 - $65,000/ yearly The Administrative aspect of our Yacht Management Accounting Department involves providing the vessel and Owner with Accounting and Reporting service. The Yacht Manag...
- 1 Month Ago
Assistant Sales Manager - FL
- Top Rx LLC
-
Lauderdale, FL
FULL_TIME
- DescriptionPOSITION SUMMARY: Directly supervise and coordinate activities of the hourly sales team members. In addition, will perform duties such as administrative support, handling of issues and othe...
- Just Posted
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0 Top Regulatory Affairs Executive jobs found in Pompano Beach, FL area
Senior Nurse Manager FT Nights $20,000 Sign on Bonus $3,000 Relocation
- Hiring Now!
-
Pompano Beach, FL
- AdventHealth 401 Palmetto St., New Smyrna Beach, FL 32168 Senior Nurse Manager FT Nights All the benefits and perks you ...
- 4/19/2024 12:00:00 AM
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
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
Senior Nurse Manager FT Nights $20,000 Sign on Bonus $3,000 Relocation
- Adventhealth New Smyrna Beach
-
Pompano Beach, FL
- AdventHealth 401 Palmetto St., New Smyrna Beach, FL 32168 Senior Nurse Manager FT Nights All the benefits and perks you ...
- 4/17/2024 12:00:00 AM
Rental Sales Representative
- Ryder System
-
Pompano Beach, FL
- Job Seekers can review the Job Applicant Privacy Policy by clicking HERE. (https://ryder.com/job-applicant-privacy-polic...
- 4/17/2024 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
Rental Sales Management Trainee
- Ryder System
-
Pompano Beach, FL
- Job Seekers can review the Job Applicant Privacy Policy by clicking HERE. (https://ryder.com/job-applicant-privacy-polic...
- 4/16/2024 12:00:00 AM
About Pompano Beach, Florida
Pompano Beach /ˌpɒmpənoʊ ˈbiːtʃ/ is a city in Broward County, Florida, United States, along the coast of the Atlantic Ocean just to the north of Fort Lauderdale. The nearby Hillsboro Inlet forms part of the Atlantic Intracoastal Waterway. As of the 2010 census the city's population was 99,845, It is a principal city of the Miami metropolitan area, which was home to an estimated 6,012,331 people at the 2015 census.
Pompano Beach is currently in the middle of a redevelopment process to revitalize its beachfront and historic downtown. The city has also been listed as one of the top real estate ma...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$282,960 to $462,929
Pompano Beach, Florida area prices
were up 2.9% from a year ago
were up 2.9% from a year ago
What does a Top Regulatory Affairs Executive do?
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ERI Economic Research Institute compiles the best salary, cost-of-living, and executive compensation survey data available.
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During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020