Regulatory Affairs Director jobs in Santa Ana, CA

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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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.
  • 9 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...
  • 11 Days Ago

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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...
  • 7 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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Clinical Affairs Program Manager
  • Fujifilm
  • Santa Ana, CA OTHER
  • Overview We are hiring a Clinical Affairs Program Manager. The Clinical Affairs Program Manager will be responsible for the development and generation of Clinical Evaluation Plans and Report (CEPs, CE...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Santa Ana, CA area

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Center Manager
  • Flightsafety International
  • Long Beach, CA
  • About FlightSafety International FlightSafety International is the worlds premier professional aviation training company...
  • 4/26/2024 12:00:00 AM

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Director, Quality and Regulatory Affairs
  • Bright Uro
  • Irvine, CA
  • About Us: Bright Uro is an early-stage medical technology company headquartered in Irvine, CA.We are building the next g...
  • 4/26/2024 12:00:00 AM

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Case Management Manager
  • Astiva Health
  • Orange, CA
  • Job Description Job Description Job Title: Case Management Manager Target Compensation Range: $120,000-$150,000/year, de...
  • 4/25/2024 12:00:00 AM

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*Remote* - Drug Product, MSAT - Principal/ Associate Director
  • Northreach
  • Irvine, CA
  • Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Ou...
  • 4/25/2024 12:00:00 AM

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Center Manager
  • FlightSafety International
  • Long Beach, CA
  • About FlightSafety International FlightSafety International is the world’s premier professional aviation training compan...
  • 4/24/2024 12:00:00 AM

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Director of Natural Resources - Southern California
  • RA Management Services
  • Orange, CA
  • Job Description Job Description Director of Natural Resources Locations in Inland Empire Greater Los Angeles | San Diego...
  • 4/24/2024 12:00:00 AM

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Manager of Laboratory
  • College Hospital of Costa Mesa
  • Costa Mesa, CA
  • Job Description Job Description Psychiatric hospital in Orange County is looking to hire a Full-Time, Day Shift Manager ...
  • 4/24/2024 12:00:00 AM

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Executive Director, Executive Director (ED) of Educational Non-Profit
  • National Healthcare & Housing Advisors
  • Santa Ana, CA
  • NHHA is seeking a passionate Director, ED! National Healthcare & Housing Advisors, The Leon Institute, is breaking barri...
  • 4/22/2024 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 Regulatory Affairs Director jobs
$187,112 to $266,491
Santa Ana, California area prices
were up 2.5% 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