Regulatory Relations Specialist jobs in Santa Ana, CA
Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Recently Added Regulatory Relations Specialist jobs
Sr. Regulatory Affairs Specialist
- BioTalent
-
Orange, CA
FULL_TIME
-
JOB RESPONSIBILITIES
This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.
GENERAL DESCRIPTION AND DUTIES
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
* Represents regulatory affairs on product development and commercialization teams.
* Ensures compliance with standards and execution of corrective actions and is the liaison with domestic and international customers and vendors.
* Prepares and oversees documentation packages for submission to global regulatory agencies. Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
* Assists with customer complaints/CAPA system.
* Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
* Monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations.
* Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
* Collaborates and takes direction from RA management.
POSITION QUALIFICATIONS
* Strong working knowledge of US and EU regulations that affect Class III medical devices.
* Experience working on cross functional projects.
* Fluent English with strong written and verbal communication skills.
* Excellent analytical thinking and problem-solving skills.
MINIMUM EDUCATION
* Bachelor's degree in a related field, a scientific degree is preferred.
MINIMUM EXPERIENCE
* 3 years of experience in a regulatory role or related area. - 9 Days Ago
Public Relations Specialist
- Bold
-
Santa Ana, CA
FULL_TIME
- Company DescriptionCreating a bold impact, in Los Angeles, California.We create campaigns that lead in platform growth-giving your company the tools needed to broadcast your message across all regions...
- 10 Days Ago
Veterinary Technician-OVERNIGHT/SWING SHIFTS
- Veterinary Surgical Specialist of Orange County
-
Tustin, CA
FULL_TIME
- DescriptionLooking to make a difference?Be part of a highly skilled team?Be a part of an innovative surgical and urgent care hospital!Overnight Technicians Needed!!We have a position for you with comp...
- 20 Days Ago
Internal Medicine RVT
- Veterinary Surgical Specialist of Orange County
-
Tustin, CA
FULL_TIME
- DescriptionLooking to make a difference?Be part of a highly skilled team?Be a part of an innovative Surgical/Urgent Care/Internal Medicine Practice!We have a position for you with competitive wages an...
- 14 Days Ago
Veterinary Client Care Representative
- Veterinary Surgical Specialist of Orange County
-
Tustin, CA
FULL_TIME
- DescriptionJob descriptionLooking to make a difference?Be part of a highly skilled team?Provide essential services for fur-family members and their parents?We have a position for you with competitive ...
- 28 Days Ago
Mgr Regulatory Affairs
- Canon Medical Systems USA, Inc.
-
Tustin, CA
FULL_TIME
- Mgr Regulatory Affairs - req1193OVERVIEWResponsible for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on re...
- 11 Days Ago
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0 Regulatory Relations Specialist jobs found in Santa Ana, CA area
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...
- 4/26/2024 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....
- 4/26/2024 12:00:00 AM
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
Regulatory Affairs Specialist
- Intellectt Inc
-
Irvine, CA
- Coursework, seminars, and/or other formal government and/or trade association training required Proven expertise in Micr...
- 4/24/2024 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 II - Neuromodulation
- Boston Scientific
-
Valencia, CA
- Recruiter: Spencer Gregory Hale Regulatory Affairs Specialist II - Neuromodulation About the role: Support the regulator...
- 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
Senior Regulatory Affairs Specialist
- QuinTalent Inc
-
Irvine, CA
- Work Location is Irvine, CA - Non-Local Candidates, please do not apply. Hybrid Monday-Friday 8am-5pm 3 days on site Tue...
- 4/22/2024 12:00:00 AM
About Santa Ana, California
Santa Ana /ˌsæntə ˈænə/ (Spanish for "Saint Anne") is the county seat and second most populous city in Orange County, California in the Los Angeles metropolitan area. The United States Census Bureau estimated its 2011 population at 329,427, making Santa Ana the 57th most-populous city in the United States.
Santa Ana is in Southern California, adjacent to the Santa Ana River, about 10 miles (16 km) from the coast. Founded in 1869, the city is part of the Greater Los Angeles Area, the second largest metropolitan area in the United States, with almost 18 million residents in 2010. Santa Ana is a ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$82,173 to $112,808
Santa Ana, California area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Regulatory Relations Specialist do?
Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards. This includes assisting with the management of regulatory examinations, inquiries and meetings. Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020