Regulatory Affairs Director jobs in Sacramento, CA

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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FDA Regulatory Affairs Specialist
  • orthogroup
  • Rancho Cordova, CA FULL_TIME
  •  FDA regulatory affairs is critical to our future growth as a medical device manufacturing company.
     
     We are seeking a regulatory affairs specialist to help design and implement a quality system to comply with FDA and ISO medical device regulations.
     
     Orthogroup is a innovative manufacturer of surgical instruments used in knee, hip and shoulder surgery, amongst others. A robust quality system is required not just by the FDA and ISO, but our customers as well. Just by obtaining ISO certification, we can more than double our business, because it opens up many potential customers that won't deal with us because we don't yet have ISO certification. We are going to heavily rely on this position to get us there by the end of this year!
     
     Job skills requirements:
    • At least three years in an active regulatory position
    • Excellent written, and verbal communication skills
    • Must be able to write SOP's, and various other regulatory procedures, forms and documents. For example, you are expected to be able to formulate the design and writing of process validations.
    • A strong working knowledge of excel and Microsoft Word.
    • A good understanding of FDA medical device and ISO regulations.
    • Must be able to perform job duties with a minimal amount of supervision.
     
     Other helpful skills -very beneficial, but not required:
    • Quality assurance and Quality Control skills to perform inspections and process validations with manufacturing engineers.
    • Blueprint reading 
    • Manufacturing Engineering skills
    • To perform validations and assembly training
    • Tool designs for product assembly.
    • Help improve/Oversee assembly procedure improvements and troubleshooting.
     
     CAD Skills a plus
     
     Job description:
     Part-time to full-time and With rather flexible hours. 
     Other job responsibilities may include manufacturing engineering and or QA/QC. 
     
     We are a small six-person company expected to experience significant growth in the next few years. As a small company we are able to work with our people to accommodate personal needs for family, etc. within reason and approval by the company. We have paid time off and medical benefits and some paid holidays.
     
     The company has a great atmosphere of teamwork and pride in our work and products. If you feel this is a good match, contact us with the résumé, and we will have a preliminary discussion on the phone prior to setting up a more formal interview. We hope to be talking with you soon!

  • 22 Days Ago

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Environmental Legislative and Regulatory Affairs Manager
  • Sacramento County, CA
  • Sacramento, CA FULL_TIME
  • The Position Come join one of Forbes Magazine's Best Employers! There is an additional 3.35% Management Differential which is added to the posted salary for this class. This is a continuous filing exa...
  • 9 Days Ago

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Regulatory Affairs Manager (Hybrid Schedule)
  • SoCalGas
  • Sacramento, CA FULL_TIME
  • About Us At SoCalGas, we believe that every Californian deserves a resilient energy future. We are working to achieve that future by empowering California to reach its sustainability goals through inn...
  • 12 Days Ago

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Environmental Legislative and Regulatory Affairs Manager
  • County of Sacramento
  • Sacramento, CA FULL_TIME
  • Come join one of Forbes Magazine's Best Employers!There is an additional 3.35% Management Differential which is added to the posted salary for this class.This is a continuous filing exam. Next filing ...
  • 12 Days Ago

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Government Affairs Director
  • California Immigrant Policy Center
  • Sacramento, CA FULL_TIME
  • The California Immigrant Policy Center (CIPC is a non-partisan, non-profit statewide organization founded in response to the 1996 passage of federal immigrant and welfare laws that profoundly affected...
  • 23 Days Ago

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Director, Government Affairs
  • WelbeHealth
  • Sacramento, CA FULL_TIME
  • Director, Government Affairs: REMOTE, CALIFORNIA *strong preference of location in Sacramento or near a WelbeHealth facility (Rosemead, CA - Pasadena, CA - North Hollywood, CA - Long Beach, CA - Modes...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Sacramento, CA area

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Chief Operating Officer
  • MORRISON
  • Sacramento, CA
  • JOB SUMMARY A leading membership-based agricultural organization is seeking a Chief Operating Officer. The COO will poss...
  • 4/18/2024 12:00:00 AM

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Executive Vice President - Insurance - Sacramento, CA
  • Insurance Relief
  • Sacramento, CA
  • Executive Vice President - Insurance - Sacramento, CA We have a fantastic opportunity for YOU!! We are looking for an Ex...
  • 4/18/2024 12:00:00 AM

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Director, Lobbyist
  • Western States Petroleum Association
  • Sacramento, CA
  • Position Summary The Director of California Policy reports to WSPA’s Sr. Director, CA Chief Lobbyist and has the followi...
  • 4/18/2024 12:00:00 AM

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Director, Lobbyist
  • Western States Petroleum Association
  • Sacramento, CA
  • Position Summary The Director of California Policy reports to WSPAs Sr. Director, CA Chief Lobbyist and has the followin...
  • 4/17/2024 12:00:00 AM

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Executive Vice President - Insurance - Sacramento, CA
  • Insurance Relief
  • Sacramento, CA
  • Executive Vice President - Insurance - Sacramento, CA We have a fantastic opportunity for YOU!! We are looking for an Ex...
  • 4/16/2024 12:00:00 AM

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Legislative Director
  • Asian Americans Advancing Justice - Asian Law Caucus
  • Sacramento, CA
  • Position: Legislative Director Type: Regular, Exempt, Full Time Position Location: Based in Sacramento, CA, Hybrid work ...
  • 4/16/2024 12:00:00 AM

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Executive Vice President - Insurance - Sacramento, CA
  • Insurance Relief
  • Sacramento, CA
  • Job Description Job Description Executive Vice President - Insurance - Sacramento, CA We have a fantastic opportunity fo...
  • 4/16/2024 12:00:00 AM

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Assistant Vice President, Operations
  • Sacramento Regional Transit
  • Sacramento, CA
  • Job Description Job Description Description THIS POSITION WILL REMAIN OPEN UNTIL FILLED. APPLICATIONS ARE REVIEWED AS RE...
  • 4/16/2024 12:00:00 AM

Sacramento (/ˌsækrəˈmɛntoʊ/ SAK-rə-MEN-toh; Spanish: [sakɾaˈmento]) is the capital city of the U.S. state of California and the seat of Sacramento County. Located at the confluence of the Sacramento River and the American River in Northern California's Sacramento Valley, Sacramento's estimated 2018 population of 501,334 makes it the sixth-largest city in California and the ninth largest capital in the United States. Sacramento is the seat of the California Assembly, the Governor of California, and Supreme Court of California, making it the state's political center and a hub for lobbying and th...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$182,718 to $260,232
Sacramento, California area prices
were up 2.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020