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)
Recently Added Regulatory Affairs Specialist jobs
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.
- 1 Month Ago
Marketing Specialist
- Chumash Enterprises
-
Santa Ynez, CA
FULL_TIME
- Overview The Marketing Specialist supports the Marketing Communications Manager with the planning, organization, and communication of marketing offers, promotions, events, and other campaigns based on...
- 17 Days Ago
Correctional Treatment Specialist (Drug Abuse Treatment Specialist)
- U.S. Department of Justice
-
Lompoc, CA
FULL_TIME
- Summary Corrections professionals who foster a humane and secure environment and ensure public safety by preparing individuals for successful reentry into our communities. Our highly-skilled, diverse,...
- 11 Days Ago
Correctional Treatment Specialist (Drug Abuse Treatment Specialist)
- US Justice, Bureau of Prisons/Federal Prison...
-
Lompoc, CA
FULL_TIME
- Duties Functions as a Drug Abuse Treatment Specialist (DATS) within a Bureau of Prisons (BOP) federal correctional facility. Provides direct services, individual therapy and/or group counseling, drug ...
- 13 Days Ago
Pet Care Specialist
- Santa Ynez Valley Humane Society & D.A.W.G.
-
Buellton, CA
FULL_TIME
- Under the direction of the Animal Care Supervisor, the Pet Care Specialist works to ensure the health, safety and overall well-being of dogs and cats at the shelter, including adoptable animals. Perfo...
- 3 Months Ago
Unit Supply Specialist
- FresnoArmyRecruitingCenter
-
Lompoc, CA
FULL_TIME
- ***NO EXPERIENCE NEEDED*** Overview:The unit supply specialist is primarily responsible for supervising or performing tasks involving the general upkeep and maintenance of all Army supplies and equipm...
- 17 Days Ago
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0 Regulatory Affairs Specialist jobs found in Lompoc, CA area
cGMP Quality Assurance Senior Manager
- Life Sciences Recruitment
-
Lompoc, CA
- As the Senior Manager of Quality Assurance, you will lead a team of quality professionals and direct and coordinate the ...
- 4/24/2024 12:00:00 AM
Licensed Therapist
- Pinnacle Treatment Centers
-
Santa Maria, CA
- Overview: We offer competitive salary, full benefits package, Paid Time Off, and opportunities for professional growth. ...
- 4/23/2024 12:00:00 AM
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 ...
- 4/22/2024 12:00:00 AM
cGMP Quality Assurance Senior Manager
- Life Sciences Recruitment
-
Lompoc, CA
- As the Senior Manager of Quality Assurance, you will lead a team of quality professionals and direct and coordinate the ...
- 4/22/2024 12:00:00 AM
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...
- 4/22/2024 12:00:00 AM
Program Analyst (Space Operations)
- Department of the Air Force - Agency Wide
-
Lompoc, CA
- Summary Click on "Learn more about this agency" button below to view Eligibilities being considered and other IMPORTANT ...
- 4/21/2024 12:00:00 AM
Water Resources Engineer (Senior Civil Engineer)
- City of Santa Maria, CA
-
Santa Maria, CA
- Salary : $105,923.48 - $128,750.70 Annually Location : Santa Maria, CA Job Type: Full-Time Job Number: FY 24-00100 Depar...
- 4/21/2024 12:00:00 AM
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...
- 4/21/2024 12:00:00 AM
About Lompoc, California
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
$81,499 to $109,221
Lompoc, California area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Regulatory Affairs Specialist do?
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