Regulatory Affairs Specialist jobs in Sacramento, 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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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!

  • 27 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...
  • 14 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 ...
  • 17 Days Ago

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Specialist, Regulatory and Compliance
  • Petco
  • Sacramento, CA FULL_TIME
  • Create a healthier, brighter future for pets, pet parents and people! If you want to make a real difference, create an exciting career path, feel welcome to be your whole self and nurture your wellbei...
  • 17 Days Ago

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RN, Regulatory Specialist
  • Adventist Health
  • Roseville, CA FULL_TIME
  • Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years. In 2019, we unveiled our WELL-certified ca...
  • Just Posted

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Strategic Communications and Public Affairs - Summer Internship
  • Lucas Public Affairs
  • Sacramento, CA FULL_TIME
  • Lucas Public Affairs, a strategic communications and public affairs firm located in downtown Sacramento, seeks qualified applicants for a full-time, paid internship to assist with client work and gene...
  • 1 Month Ago

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0 Regulatory Affairs Specialist jobs found in Sacramento, CA area

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Compliance Officer - Title 31
  • Integrity+
  • Sacramento, CA
  • Compliance Manager Position Summary As a Team Member of the Finance team, the Compliance Manager is an Ambassador and ta...
  • 4/23/2024 12:00:00 AM

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Personal Banker - Roving Sierra Valley District
  • Wells Fargo Bank
  • Sacramento, CA
  • Why Wells Fargo:Are you ready for the next step in your career? This is where it begins - at a company known for our 'We...
  • 4/22/2024 12:00:00 AM

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Internal Revenue Agent (Examiner) - Direct Hire, 12 Month Register AMENDED
  • Department Of The Treasury
  • Sacramento, 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

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Assistant Branch Manager (Sales & Service) FT Sacramento, CA Arden branch
  • BNP Paribas Bank NV
  • Sacramento, CA
  • We are looking for **Assistant Branch Manager (Sales & Service) FT Sacramento, CA Arden branch** **Location** At Bank of...
  • 4/22/2024 12:00:00 AM

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Deputy Director, Finance
  • Sacramento County, CA
  • Sacramento, CA
  • Salary : $183,013.20 - $201,763.44 Annually Location : Sacramento, CA Job Type: Permanent Full-Time Job Number: 29641-B ...
  • 4/21/2024 12:00:00 AM

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Retirement Plan Education Specialist
  • Voya Financial, Inc.
  • Sacramento, CA
  • Together we fight for everyone's opportunity for a better financial future. We will do this together - with customers, p...
  • 4/21/2024 12:00:00 AM

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Workday Certified Prism Financial Reporting Manager
  • Accenture
  • Sacramento, CA
  • We are We are a global collective of innovators applying the New every day to improve the way the world works and lives....
  • 4/20/2024 12:00:00 AM

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Finance Transformation, Business Consulting Finance Senior Manager
  • EY
  • Sacramento, CA
  • EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these q...
  • 4/20/2024 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 Specialist jobs
$82,106 to $110,035
Sacramento, 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