Top Regulatory Affairs Executive jobs in Pembroke Pines, 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 Pembroke Pines, FL area
Store Manager
- Baskin Robbins
-
Fort Lauderdale, FL
- **Store Manager** Responsible for directing the daily operations of a single store. Operates in accordance with prescrib...
- 4/23/2024 12:00:00 AM
Expansion Project Administrator (HBMD)
- Broward County, FL
-
Pompano Beach, FL
- Salary : $91,157.25 - $145,487.31 Annually Location : Pompano Beach, FL Job Type: Full-Time Job Number: 1412036 Departme...
- 4/23/2024 12:00:00 AM
Clinical Pharmacist (Full-Time)
- Larkin Community Hospital
-
Hollywood, FL
- Job Description * Monitor drug therapy for assigned patients, assessing therapeutic endpoints and potential adverse effe...
- 4/23/2024 12:00:00 AM
Operating Room Nurse Manager
- Texas Nursing Services
-
Pompano Beach, FL
- ???? JOB OPPORTUNITY: RN Nurse Manager Operating Room - Margate, FL ????$40/hr. - $75/hr.???? Location: Margate, FL 3306...
- 4/23/2024 12:00:00 AM
Assistant Director - Public Works
- City Of Margate
-
Pompano Beach, FL
- Assistant Director - Public Works Closes On: September 30, 2024 at 11:59 PM EST Department:Public Works Division:Public ...
- 4/22/2024 12:00:00 AM
Bartender Part Time (Harrah's Pompano Beach)
- Caesars Entertainment
-
Pompano Beach, FL
- Job Description ESSENTIAL DUTIES & RESPONSIBILITIES General: Deal with high-volume customer interactions and be consiste...
- 4/22/2024 12:00:00 AM
Phlebotomist (Bilingual-English/Spanish)
- Octapharma Plasma
-
Pembroke Pines, FL
- Want to Expand your career-development potential, your ability to help donors and patients, and your access to professio...
- 4/22/2024 12:00:00 AM
Senior Nurse Manager FT Nights $20,000 Sign on Bonus $3,000 Relocation
- Hiring Now!
-
Deerfield Beach, FL
- AdventHealth 401 Palmetto St., New Smyrna Beach, FL 32168 Senior Nurse Manager FT Nights All the benefits and perks you ...
- 4/22/2024 12:00:00 AM
About Pembroke Pines, Florida
Pembroke Pines is a city in southern Broward County, Florida, United States. Pembroke Pines' current population is estimated at 170,712 as of 2017. The city had a population of 154,750 as of the 2010 census, making it the second-most populous city in Broward County after Fort Lauderdale, and the 11th-most populous in Florida. It is a principal city of the Miami metropolitan area, which was home to an estimated 6,012,331 people in 2015.
Pembroke Pines is located in southern Broward County at 26°00′46″N 80°18′49″W / 26.012913°N 80.313689°W / 26.012913; -80.313689.
According to the United Stat...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$281,202 to $460,054
Pembroke Pines, 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.
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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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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