Regulatory Affairs Specialist jobs in Fullerton, 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 Consultant
- eTeam
-
Diamond, CA
FULL_TIME
- Company DescriptioneTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50Job DescriptionDevelop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.ESSENTIAL DUTIES AND RESPONSIBILITIESWith moderate supervision, responsible for the following Regulatory activities:• Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.• Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.• Author technical files and design dossiers for products to be distributed in the EU.• Prepare international documentation to support product registration internationally.• Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.• Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures.• Participate on new product development teams.• Review and approve new product development and product modification documentation.• Write, review and revise company SOPs as required.• Communicate business related issues or opportunities to next management level.• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.• Perform other duties assigned as needed.Qualifications• BS degree in Engineering, Physical or Biological science a minimum of 4 - 6 years experience in Regulatory experience or advanced degree 2 - 4 years experience in Regulatory Affairs.REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:• Must be familiar with MS Office applications• Excellent communication skills (verbal and written)• Project management skills• Problem solving skills• Presentation skills• RAC Certification preferredAdditional InformationThanks & RegardsNeha SharmaLead RecruitereTeam Inc – “ACCELERATED HIRES”Efficiency, Synergy, ExpertiseT-732-248-1900 .Ext 120Awards#1 Best Places to work in New Jersey-2009,2008,2007,2006 Top Small Diversity Business, 2006 by DiversityBusiness.comDeloitte Technology Fast 500-2007,2006IMPORTANT NOTE: Under Bills.1618 Title III passed by the 105th U.S. Congress, this email cannot be considered spam as long as it contains our contact information and a link for the removal requests. If you have received this mail in error or prefer not to receive such emails in the future, please reply with "REMOVE" in the subject line and the email id(s) to be removed. All removal requests will be honored ASAP. We sincerely apologize for any inconvenience caused.
- 1 Month Ago
Regulatory Policy Specialist [HYBRID]
- Southern California Edison
-
Westminster, CA
FULL_TIME
- Job DescriptionJoin the Clean Energy RevolutionBecome a Regulatory Policy Specialist at Southern California Edison (SCE) and build a better tomorrow. In this job, you'll help develop and execute SCE's...
- 27 Days Ago
Student Affairs Specialist
- Marshall B Ketchum University
-
Fullerton, CA
FULL_TIME
- Reporting to the Vice President for Enrollment and Student Services, the Student Affairs, Specialist is a student affairs generalist with some experiences and background related to student engagement,...
- 23 Days Ago
Regulatory Compliance Specialist (Bilingual in Korean)
- Pulmuone Foods USA
-
Fullerton, CA
FULL_TIME
- Company Overview Pulmuone’s mission is a company that creates a healthy future for people and the earth with wholesome foods. Pulmuone Foods USA brands include Nasoya, Wildwood, Emerald Valley Kitchen...
- 12 Days Ago
Family Nurse Practitioner (Min 2 years experience)
- Huntington Specialist Med Grp
-
Chino, CA
CONTRACTOR,FULL_TIME,PART_TIME
- Join our growing Hospitalist team!! The Hospitalist position available is located in both Chino Hills, CA & The City of Alhambra in Los Angeles County. Both Primary Care and Acute Care experience are ...
- 11 Days Ago
Shop helper at Cylinder Head Shop
- Quality Cylinder Head Specialist Inc.
-
Stanton, CA
FULL_TIME
- We are an automotive machine shop that rebuilds cylinder heads. We are looking for someone who can start full time and will stay with us for a long time. We are looking for someone we can train to bec...
- 14 Days Ago
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0 Regulatory Affairs Specialist jobs found in Fullerton, CA area
Regulatory Affairs Specialist
- Kelly Science, Engineering, Technology & Telecom
-
Irvine, CA
- Regulatory Affairs Specialist (hybrid) Kelly Science and Clinical FSP is currently seeking a medical device Regulatory A...
- 4/24/2024 12:00:00 AM
Sr. Regulatory Affairs Specialist
- Cypress HCM
-
Los Angeles, CA
- Sr. Regulatory Affairs Specialist Location: Los Angeles, Ca Company Size: 200/ Team Size: 15 Duties & Responsibilities: ...
- 4/23/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- NeuroVasc Technologies, Inc.
-
Irvine, CA
- We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world....
- 4/23/2024 12:00:00 AM
Regulatory Affairs Specialist
- Cypress HCM
-
Irvine, CA
- Regulatory Affairs Specialist This is an exciting opportunity to join an industry leading biotech company leading. The R...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist - Contract
- Nihon Kohden America
-
Irvine, CA
- The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining a...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist (IVD)
- Nelson Connects
-
Irvine, CA
- Location: Irvine, CA Shift: 8am-5pm (hybrid) Type: 12 month assignment (Temporary) Industry: Life Science Pay Range: $40...
- 4/22/2024 12:00:00 AM
Sr. Regulatory Affairs Specialist
- Redbock - an NES Fircroft company
-
Irvine, CA
- Senior Regulatory Affairs Specialist will be responsible for implementing regulatory strategies, assisting with the prep...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist (IVD)
- Nelson Connects
-
Irvine, CA
- Location: Irvine, CA Shift: 8am-5pm (hybrid) Type: 12 month assignment (Temporary) Industry: Life Science Pay Range: $40...
- 4/21/2024 12:00:00 AM
About Fullerton, California
Fullerton (/ˈfʊlərtən/) is a city located in northern Orange County, California, United States. As of the 2010 census, the city had a total population of 135,161.
Fullerton was founded in 1887. It secured the land on behalf of the Atchison, Topeka and Santa Fe Railway. Historically it was a center of agriculture, notably groves of Valencia oranges and other citrus crops; petroleum extraction; transportation; and manufacturing. It is home to numerous higher educational institutions, particularly California State University, Fullerton and Fullerton College. From the mid-1940s through the late 19...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$84,233 to $112,886
Fullerton, California area prices
were up 3.2% from a year ago
were up 3.2% 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