Top Regulatory Affairs Executive jobs in Hollywood, 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 ...
- 8 Days 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...
- 1 Month 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
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...
- 6 Days 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
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0 Top Regulatory Affairs Executive jobs found in Hollywood, FL area
Stylist - 7FAM
- Delta Galil USA Inc
-
Miami, FL
- Stylist (Part-Time) Position Summary: Join 7 For All Mankind, the first company to bring premium denim to the market, pu...
- 4/26/2024 12:00:00 AM
Real Estate Paralegal
- Turnberry
-
Aventura, FL
- Turnberry is a leader in the design, development, and management of multi-use real estate properties. We create exceptio...
- 4/25/2024 12:00:00 AM
Senior Specialist, Quality Control
- Velocity Clinical Research, Inc.
-
Hallandale, FL
- Overview: Velocity Clinical Research is an owned and integrated research site organization, providing excellence in pati...
- 4/25/2024 12:00:00 AM
Maintenance Manager
- Turnberry
-
Aventura, FL
- About Us Aventura Mall is the premier shopping destination in Miami and South Florida and one of the top shopping center...
- 4/24/2024 12:00:00 AM
Summer Camp Site Supervisor
- YMCA of South Florida
-
Hollywood, FL
- Under the direction of the Associate Executive Director, the Site Supervisor responsible for the overall operations and ...
- 4/23/2024 12:00:00 AM
Human Resources Specialist
- Contact Government Services, LLC
-
Hollywood, FL
- A Washington, D.C. based government contracting firm is seeking an internal Human Resource and Payroll Specialist to run...
- 4/23/2024 12:00:00 AM
Sr. Formulator
- Florida Supplement
-
Hollywood, FL
- POSITION OBJECTIVE Responsible for the evaluation and development of nutraceutical formulas and formulation functions th...
- 4/23/2024 12:00:00 AM
Principal Investigator
- Velocity Clinical Research, Inc.
-
Hallandale, FL
- Overview: Velocity Clinical Research is an owned and integrated research site organization, providing excellence in pati...
- 4/22/2024 12:00:00 AM
About Hollywood, Florida
Hollywood is a city in Broward County, Florida, between Fort Lauderdale and Miami. The average temperature is between 68 and 83 °F (20 and 28 °C). As of July 1, 2017, Hollywood had a population of 153,627. Founded in 1925, the city grew rapidly in the 1950s and 1960s, and is now the twelfth-largest city in Florida. Hollywood is a principal city of the Miami metropolitan area, which was home to an estimated 6,012,331 people at the 2015 census.
Hollywood is located at 26°1′17″N 80°10′30″W / 26.02139°N 80.17500°W / 26.02139; -80.17500 (26.021467, -80.174910).
According to the United States Cen...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$282,960 to $462,929
Hollywood, 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?
Top Regulatory Affairs Executive in Santa Ana, CA
Based on our compensation data, the estimated salary potential for Top Regulatory Affairs Executive will increase 16 % over 5 years.
February 05, 2020
Top Regulatory Affairs Executive in Wilmington, DE
ERI Economic Research Institute compiles the best salary, cost-of-living, and executive compensation survey data available.
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Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020