Regulatory Affairs Specialist jobs in Lompoc, 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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Regulatory Affairs Specialist
  • Agile Enterprise Solutions
  • Lompoc, CA FULL_TIME
  • Company Description Medical Industry Job DescriptionIn detailed Job Description:Under general direction, will oversee Regulatory, Quality Assurance & Compliance and develop and implement department goals, objectives, and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA and applicable international regulatory bodies and/or standards. Essential Duties and Responsibilities include the following. Other duties may be assigned.Required Skills· Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.· Knowledge of regulatory submissions (IDE, 510(k), etc.).· Ability to develop effective quality systems and regulatory strategies and programs.· Ability to demonstrate excellent organizational, leadership, reasoning, judgment, and interpersonal skills. The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of the job, the employee is regularly required to sit; talk and hear; use one or both hands to finger, handle or feel; use a simple grasp; and occasionally required to stand, walk, grasp with one or both hands; and to lift and/or move up to 10 lbs. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet. Required Experience Bachelor’s degree (B.S.) from four-year college or university; and ten years as managerial experience in quality assurance and/or regulatory experience in manufacturing medical devices; or equivalent combination of education and experience. Advanced degree and experience in the medical device manufacturing quality assurance area preferred.· Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.· Knowledge of regulatory submissions (IDE, 510(k), etc.).· Ability to develop effective quality systems and regulatory strategies and programs.· Ability to demonstrate excellent organizational, leadership, reasoning, judgment, and interpersonal skills.· QualificationsBachelor Engineer Additional InformationAll your information will be kept confidential according to EEO guidelines.
  • 10 Days Ago

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Employment specialist
  • County of Santa Barbara
  • Lompoc, CA FULL_TIME
  • Description SALARY $4,461.39 - $5,320.76 Monthly $53,536.72 - $63,849.18 Annually Plus bilingual allowance when applicable The County of Santa Barbara offers generous benefits including the following ...
  • 18 Days Ago

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Environmental Specialist
  • Chumash Enterprises
  • Santa Ynez, CA FULL_TIME
  • Overview The Environmental Specialist takes the lead on grant programs, assisting with activities including project planning and implementation, community education and outreach, financial and grants ...
  • 23 Days Ago

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Communications Specialist
  • Chumash Enterprises
  • Santa Ynez, CA FULL_TIME
  • Overview The Communications Specialist plays a key role in ensuring change initiatives meet objectives on time and on budget by increasing Team Member adoption and usage. Focuses on the stakeholder en...
  • 1 Month Ago

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Checkout Specialist
  • Chumash Enterprises
  • Santa Ynez, CA FULL_TIME
  • Overview At the direction of the Director of Operations, the Checkout Specialist interacts with patients and staff to checkout patients, collect funds, and schedule future appointments. Responsible fo...
  • 1 Month Ago

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Engagement Specialist
  • Chumash Enterprises
  • Buellton, CA FULL_TIME
  • Overview Under the direction of Engagement Manager, the Engagement Specialist is responsible for assisting with the development, execution, and evaluation of Team Member engagement initiatives for Chu...
  • 2 Months Ago

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0 Regulatory Affairs Specialist jobs found in Lompoc, CA area

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Chemist
  • Department of Defense
  • Lompoc, CA
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/28/2024 12:00:00 AM

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Inventory Specialist
  • WALGREENS
  • Santa Maria, CA
  • Responsible for executing, monitoring, and training inventory best practices and standard operating procedures for the e...
  • 3/28/2024 12:00:00 AM

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Assistant Community Manager-New Lease Up
  • Aperto Property Management, Inc.
  • Santa Maria, CA
  • Job Description Job Description Aperto Property Management, Inc is a full-service, fee-based apartment management compan...
  • 3/28/2024 12:00:00 AM

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Internal Revenue Agent (Examiner) - DIRECT HIRE (12 MONTH REGISTER) AMENDED
  • Department Of The Treasury
  • Santa Maria, CA
  • Duties WHAT ARE THE APPEALS (AP), LARGE BUSINESS AND INTERNATIONAL (LB&I), SMALL BUSINESS SELF-EMPLOYED (SB/SE) AND TAX ...
  • 3/27/2024 12:00:00 AM

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Pharmacist
  • Department of Defense
  • Lompoc, CA
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/27/2024 12:00:00 AM

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Health Physicist
  • Department of Defense
  • Lompoc, CA
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/27/2024 12:00:00 AM

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Affordable Housing Community Manager - Rancho Garden
  • Solari Enterprises, Inc.
  • Santa Maria, CA
  • Job Description Job Description Position Overview: A full-time, non-exempt, community manager for community located in S...
  • 3/27/2024 12:00:00 AM

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Physical Therapist - PT - Rehab
  • CareerStaff Unlimited
  • Santa Maria, CA
  • Physical Therapist - PT - Rehab Invest in your future by discovering a facility in Santa Maria, CA with resources, techn...
  • 3/27/2024 12:00:00 AM

Lompoc (/ˈlɒmpoʊk/, LOM-poke) (Purisimeño: Lompo', "Stagnant Water" ; Spanish: Lumpoco) is a city in Santa Barbara County, California, on the west coast of the United States. The city was incorporated on August 13, 1888. The population was 42,434 at the 2010 census, up from 41,103 at the 2000 census. Before European settlers arrived, the area around Lompoc was inhabited by the Chumash people. The name of the city is derived from a Purisimeño term, "Lum Poc", which means "stagnant waters" or "lagoon". The Spanish called it "Lumpoco". In 1837, the Mexican government sold the area as the Rancho L...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$81,225 to $108,853
Lompoc, 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