Top Regulatory Affairs Executive jobs in Fort Lauderdale, 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 ...
- 11 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...
- 9 Days Ago
Top Loader 1
- Seacor Holding Inc
-
Dania, FL
FULL_TIME
- SEACOR is a diverse family of businesses with career opportunities of all kinds open to dedicated people.Preferred Qualifications:Education: High school diploma / EquivalentExperience: 2 YearsLanguage...
- 20 Days Ago
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0 Top Regulatory Affairs Executive jobs found in Fort Lauderdale, FL area
Construction Project Management Supervisor (Construction Management Division)
- Broward County (FL)
-
Fort Lauderdale, FL
- The Broward County Board of County Commissioners is seeking qualified candidates for Construction Project Management Sup...
- 4/28/2024 12:00:00 AM
Junior/Assistant Property Manager
- FirstService Corporation
-
Fort Lauderdale, FL
- Job Overview: As an Jr. Manger, you'll be responsible for assisting in the management of properties in accordance with c...
- 4/28/2024 12:00:00 AM
Community Manager
- RPM Living
-
Fort Lauderdale, FL
- Overview: Looking for something different? We ARE that something different at RPM Living. Dynamic and fast growth cultur...
- 4/28/2024 12:00:00 AM
Chemist
- The Clorox Company
-
Fort Lauderdale, FL
- Clorox is the place thats committed to growth for our people and our brands. Guided by our purpose and values, and with ...
- 4/27/2024 12:00:00 AM
Department Manager-Civil/Site
- Colliers Engineering & Design
-
Fort Lauderdale, FL
- Overview: Colliers Engineering & Design is looking for a Department Manager who will be responsible for the professional...
- 4/27/2024 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...
- 4/26/2024 12:00:00 AM
Embedded Software Engineer AUTOSAR C++
- TechDigital Corporation
-
Fort Lauderdale, FL
- Summary: You will be involved in the design, implementation, and validation of software for a variety of vehicle feature...
- 4/25/2024 12:00:00 AM
Physical Therapist SL - PRN
- Healthpro Heritage, LLC
-
Fort Lauderdale, FL
- Overview: At HealthPro Heritage we hire people who share our vision, who work diligently and provide the kind of care th...
- 4/24/2024 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 Top Regulatory Affairs Executive jobs
$282,960 to $462,929
Fort Lauderdale, 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.
February 01, 2020
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