Top Regulatory Affairs Executive jobs in Santa Ana, CA

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)

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Sr. Regulatory Affairs Specialist
  • BioTalent
  • Orange, CA FULL_TIME
  • JOB RESPONSIBILITIES



    This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.



    GENERAL DESCRIPTION AND DUTIES



    To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



    * Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
    * Represents regulatory affairs on product development and commercialization teams.
    * Ensures compliance with standards and execution of corrective actions and is the liaison with domestic and international customers and vendors.
    * Prepares and oversees documentation packages for submission to global regulatory agencies. Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
    * Assists with customer complaints/CAPA system.
    * Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
    * Monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations.
    * Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
    * Collaborates and takes direction from RA management.



    POSITION QUALIFICATIONS



    * Strong working knowledge of US and EU regulations that affect Class III medical devices.
    * Experience working on cross functional projects.
    * Fluent English with strong written and verbal communication skills.
    * Excellent analytical thinking and problem-solving skills.



    MINIMUM EDUCATION

    * Bachelor's degree in a related field, a scientific degree is preferred.



    MINIMUM EXPERIENCE

    * 3 years of experience in a regulatory role or related area.
  • 7 Days Ago

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Mgr Regulatory Affairs
  • Canon Medical Systems USA, Inc.
  • Tustin, CA FULL_TIME
  • Mgr Regulatory Affairs - req1193OVERVIEWResponsible for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on re...
  • 9 Days Ago

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Retail Sales Associate and Cashier
  • Top Canvas
  • Tustin, CA PART_TIME,FULL_TIME
  • We are a retail toy and collectible/ claw machine entertainment store located in Tustin. We seek a dynamic and driven Retail Sales Associate to join our team. The Retail Sales Associate will be respon...
  • Just Posted

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Clinical Affairs Specialist (CAS)
  • Talentry
  • Santa Ana, CA FULL_TIME
  • Clinical Affairs Specialist (CAS)Direct Hire. Medical Device.Santa Ana, CA. 70-95k Talentry is looking for a Clinical Affairs Specialist (CAS) to manage the internal biocollection program and to suppo...
  • 5 Days Ago

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Vice President, Academic Affairs
  • Rancho Santiago Community College District
  • Santa Ana, CA FULL_TIME
  • Vice President, Academic Affairs Rancho Santiago Community College District Salary Range: Grade A: $155,004.61 - $207,721.00/year, $218,107.05 (top step effective 7/01/2022), $229.012.40 (top step eff...
  • 1 Month Ago

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Dean, Student Affairs
  • Rancho Santiago Community College District
  • Santa Ana, CA FULL_TIME
  • Dean, Student Affairs Rancho Santiago Community College District Salary Range: Grade B: $159,960.27 - $214,362.05/year, $225,080.15 (top Step effective 7/01/2023) Job Type: Full-Time Management - Acad...
  • 1 Month Ago

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0 Top Regulatory Affairs Executive jobs found in Santa Ana, CA area

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Regulatory Affairs Specialist
  • Kelly Science, Engineering, Technology & Telecom
  • Irvine, CA
  • Regulatory Affairs Specialist (hybrid) Kelly Science and Clinical FSP is currently seeking a medical device Regulatory A...
  • 4/24/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Intellectt Inc
  • Irvine, CA
  • Coursework, seminars, and/or other formal government and/or trade association training required Proven expertise in Micr...
  • 4/24/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • NeuroVasc Technologies, Inc.
  • Irvine, CA
  • We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world....
  • 4/23/2024 12:00:00 AM

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Sr. Regulatory Affairs Specialist
  • Cypress HCM
  • Los Angeles, CA
  • Sr. Regulatory Affairs Specialist Location: Los Angeles, Ca Company Size: 200/ Team Size: 15 Duties & Responsibilities: ...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Cypress HCM
  • Irvine, CA
  • Regulatory Affairs Specialist This is an exciting opportunity to join an industry leading biotech company leading. The R...
  • 4/22/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • QuinTalent Inc
  • Irvine, CA
  • Work Location is Irvine, CA - Non-Local Candidates, please do not apply. Hybrid Monday-Friday 8am-5pm 3 days on site Tue...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist (IVD)
  • Nelson Connects
  • Irvine, CA
  • Location: Irvine, CA Shift: 8am-5pm (hybrid) Type: 12 month assignment (Temporary) Industry: Life Science Pay Range: $40...
  • 4/21/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Neurovasc Technologies Inc.
  • Irvine, CA
  • We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world....
  • 4/21/2024 12:00:00 AM

Santa Ana /ˌsæntə ˈænə/ (Spanish for "Saint Anne") is the county seat and second most populous city in Orange County, California in the Los Angeles metropolitan area. The United States Census Bureau estimated its 2011 population at 329,427, making Santa Ana the 57th most-populous city in the United States. Santa Ana is in Southern California, adjacent to the Santa Ana River, about 10 miles (16 km) from the coast. Founded in 1869, the city is part of the Greater Los Angeles Area, the second largest metropolitan area in the United States, with almost 18 million residents in 2010. Santa Ana is a ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$324,261 to $530,500
Santa Ana, California area prices
were up 2.5% from a year ago

Top Regulatory Affairs Executive in Santa Ana, CA
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