Regulatory Affairs Manager jobs in Lompoc, 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)

A
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

B
Turns Manager
  • Balfour Beatty Investments - North America
  • Lompoc, CA FULL_TIME
  • Who we are At Balfour Beatty Communities, we are dedicated to a singular mission: delivering the quality communities people are proud to call home. We believe exceptional living experiences can only b...
  • 20 Days Ago

8
Project Manager
  • 8615 Imerys Performance Minerals Americas, Inc.
  • Lompoc, CA PART_TIME
  • The Company The world’s leading supplier of mineral-based specialty solutions for industry with 14,000 employees, operations in more than 40 countries, and €4.3 billion in revenue in 2022. Imerys deli...
  • 21 Days Ago

R
Regional Manager
  • Rainey Property Management
  • Lompoc, CA FULL_TIME
  • ABOUT THE ORGANIZATION Rainey Property Management (Rainey) offers best-in-class management services and operation of apartment communities. Rainey provides owners of multi-family communities with a fu...
  • Just Posted

J
Assistant Manager
  • Jack in the Box - 5411
  • Buellton, CA FULL_TIME
  • Responsible for managing restaurant operations, in conjunction with or in the absence of the Restaurant Manager. Uses discretion in daily management decisions with accountability for ensuring effectiv...
  • 9 Days Ago

J
Assistant Manager
  • Jack in the Box, an independently owned Franchise
  • Lompoc, CA FULL_TIME
  • Responsible for managing restaurant operations, in conjunction with or in the absence of the Restaurant Manager. Uses discretion in daily management decisions with accountability for ensuring effectiv...
  • 25 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in Lompoc, CA area

D
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 ...
  • 4/26/2024 12:00:00 AM

D
Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Santa Maria, 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

W
Order Picker
  • Walmart
  • Lompoc, CA
  • **Job Summary:** As an Order Picker at Walmart, you will be responsible for accurately and efficiently selecting merchan...
  • 4/26/2024 12:00:00 AM

C
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...
  • 4/26/2024 12:00:00 AM

D
Supervisory Legal Admin Specialist (Estate & Gift Tax) 12 month register Direct Hire Amended
  • Department Of The Treasury
  • Santa Maria, 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

S
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...
  • 4/26/2024 12:00:00 AM

L
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

L
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

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 Manager jobs
$147,816 to $208,502
Lompoc, 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