Regulatory Affairs Manager jobs in Santa Ana, CA

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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 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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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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0 Regulatory Affairs Manager jobs found in Santa Ana, CA area

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Executive Chef
  • COREcruitment Ltd
  • Santa Clarita, CA
  • Executive Chef - (Golf Club) Salary: $95,000 - $115,000 Location: Santa Clarita, CA I am thrilled to announce my collabo...
  • 4/26/2024 12:00:00 AM

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Sr. Payroll Compliance Manager
  • Suna Solutions
  • Cerritos, CA
  • Job Title: Payroll Compliance Sr Mgr/Director Pay Rate: $110K to $125K Duration: Full Time Location: Cerritos, CA 90703 ...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Coordinator
  • Josie Maran
  • Los Angeles, CA
  • JOSIE MARAN REGULATORY AFFAIRS COORDINATOR WHO WE ARE Josie Maran is the pioneer of clean, Argan oil-powered beauty. The...
  • 4/26/2024 12:00:00 AM

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Wetlands Permitting Specialist
  • 347 Group, Inc.
  • Santa Ana, CA
  • Job Description Job Description We have an excellent opportunity for a Senior Regulatory Permitting Specialist with dire...
  • 4/26/2024 12:00:00 AM

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Santa Ana, CA
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Delegation Oversight Specialist
  • Heritage Provider Network
  • Orange, CA
  • Job Description The delegation oversight specialist supports the Delegation Oversight team in the management and monitor...
  • 4/25/2024 12:00:00 AM

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Senior Manager, Regulatory Affairs - Cell Therapies (Remote-based)
  • Fresenius Kabi Usa Llc
  • Los Angeles, CA
  • Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help de...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Coordinator
  • Josie Maran
  • Los Angeles, CA
  • JOSIE MARAN REGULATORY AFFAIRS COORDINATOR WHO WE ARE Josie Maran is the pioneer of clean, Argan oil-powered beauty. The...
  • 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 Manager jobs
$152,499 to $215,109
Santa Ana, California area prices
were up 2.5% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020