Regulatory Affairs Director jobs in Fort Lauderdale, FL

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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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

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Regulatory specialist
  • State of Florida
  • Margate, FL FULL_TIME
  • Requisition No : 827889 Agency : Business and Professional Regulations Working Title : Regulatory Specialist I - DBPR / Hotels and Restaurants - Broward County OPEN COMPETITIVE Pay Plan : Career Servi...
  • Just Posted

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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

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Regulatory Compliance Coordinator
  • City of Lauderhill
  • Lauderhill, FL FULL_TIME
  • Under the general direction of the Director of DEES, provides administrative, supervisory position reports to the Engineering Division of the City's Department of Engineering & Environmental Services ...
  • Just Posted

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VP - REGULATORY & COMPLIANCE
  • Hard Rock International (USA), Inc.
  • Hollywood, FL FULL_TIME
  • Overview The Vice President, Regulatory and Compliance to provide regulatory and compliance analysis and guidance on a global basis to the senior management team of the company. Responsibilities Essen...
  • 1 Month Ago

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VP - REGULATORY & COMPLIANCE
  • Hard Rock Cafe International (USA), Inc.
  • Hollywood, FL FULL_TIME
  • Overview The Vice President, Regulatory and Compliance to provide regulatory and compliance analysis and guidance on a global basis to the senior management team of the company. Responsibilities Essen...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Fort Lauderdale, FL area

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Community Association Manager
  • SABAL PALM CONDOMINIUMS OF PINE
  • Davie, FL
  • Job Description Job Description Community Association Manager The Cream Group & Sabal Palm Condominiums is excited to we...
  • 4/25/2024 12:00:00 AM

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Director of Technical Records
  • GA Telesis, LLC
  • Fort Lauderdale, FL
  • GA Telesis is a global leader providing integrated solutions to the aviation and aerospace industries. We serve over 3,0...
  • 4/24/2024 12:00:00 AM

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Director of Telemetry
  • Pyramid Consulting, Inc
  • Fort Lauderdale, FL
  • Immediate need for a talented Director of Telemetry. This is a Fulltime opportunity with long-term potential and is loca...
  • 4/24/2024 12:00:00 AM

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Director of Technical Records
  • GA Telesis
  • Fort Lauderdale, FL
  • GA Telesis is a global leader providing integrated solutions to the aviation and aerospace industries. We serve over 3,0...
  • 4/23/2024 12:00:00 AM

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Director of Operations
  • Obvius Robotics Inc.
  • Fort Lauderdale, FL
  • An exciting opportunity to be in the initial stage of establishing manufacturing operations at OBVIUS Robotics, a well-c...
  • 4/23/2024 12:00:00 AM

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Lead and Copper Regional Lead-Charlotte,NC
  • Black & Veatch
  • Pompano Beach, FL
  • **Lead and Copper Regional Lead-Charlotte,NC**Date: Mar 27, 2024Location:Charlotte, TX, US USCompany: Black & Veatch Fam...
  • 4/23/2024 12:00:00 AM

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Director of Operations
  • Point Blank Enterprises, Inc.
  • Pompano Beach, FL
  • Job Title: Director of Operations Location: Pompano Beach, Florida (with regular travel to Puerto Rico and the Dominican...
  • 4/21/2024 12:00:00 AM

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Director of Operations
  • Point Blank Enterprises Inc.
  • Pompano Beach, FL
  • Job Title: Director of Operations Location: Pompano Beach, Florida (with regular travel to Puerto Rico and the Dominican...
  • 4/21/2024 12:00:00 AM

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 Director jobs
$163,280 to $232,548
Fort Lauderdale, Florida area prices
were up 2.9% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020