Regulatory Affairs Specialist jobs in Santa Ana, CA

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (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.
  • 5 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...
  • 7 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...
  • 3 Days Ago

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Veterinary Technician-OVERNIGHT/SWING SHIFTS
  • Veterinary Surgical Specialist of Orange County
  • Tustin, CA FULL_TIME
  • DescriptionLooking to make a difference?Be part of a highly skilled team?Be a part of an innovative surgical and urgent care hospital!Overnight Technicians Needed!!We have a position for you with comp...
  • 16 Days Ago

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Internal Medicine RVT
  • Veterinary Surgical Specialist of Orange County
  • Tustin, CA FULL_TIME
  • DescriptionLooking to make a difference?Be part of a highly skilled team?Be a part of an innovative Surgical/Urgent Care/Internal Medicine Practice!We have a position for you with competitive wages an...
  • 10 Days Ago

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Veterinary Client Care Representative
  • Veterinary Surgical Specialist of Orange County
  • Tustin, CA FULL_TIME
  • DescriptionJob descriptionLooking to make a difference?Be part of a highly skilled team?Provide essential services for fur-family members and their parents?We have a position for you with competitive ...
  • 24 Days Ago

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

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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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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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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...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Curtis Food Recruiters
  • Los Angeles, CA
  • Simply Good Foods is seeking a Regulatory Affairs Specialist to support continued growth. This is a critical role for th...
  • 4/22/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist
  • Philips
  • Orange, CA
  • Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist (U.S. Hub based l...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist - Contract
  • Nihon Kohden America
  • Irvine, CA
  • The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining a...
  • 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 Regulatory Affairs Specialist jobs
$84,081 to $112,682
Santa Ana, California area prices
were up 2.5% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020