Regulatory Affairs Specialist jobs in Huntington Beach, 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
Principal Regulatory Affairs Specialist
- Vertos Medical
-
Aliso Viejo, CA
FULL_TIME
-
Position: Principal Regulatory Affairs Specialist Location: Aliso Viejo, CA
Job Id: 248 # of Openings: 0 Principal Regulatory Affairs SpecialistPOSITION SUMMARYAn individual contributor who serves as a primary regulatory representative and Subject Matter Expert (SME) within the functional group, providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, EU MDD/MDR, ISO standards, and other regulatory requirements. Provide support for the regulatory department, including submission support and maintenance of existing product related files/reports, to ensure that deadlines are met.ESSENTIAL FUNCTIONS OF THE POSITION- Represent the regulatory function on product development teams to provide guidance and direction, inclusive of potential risks, to the cross-functional team; identify risk-based solutions and strategies for problem solving.
- Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packing, manufacturing process and facility.
- Review and approve protocols, reports, engineering drawings, procedures, and other product development documentation to ensure regulatory requirements compliance, consistency, and accuracy.
- Support product maintenance for currently marketed products, as necessary.
- Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications and internal Letters to File, as applicable.
- Prepare and oversee documentation packages for submission to global regulatory agencies; track timelines and document milestone achievements for inclusion in regulatory submissions; interact with regulatory agencies as part of submission review and on-site audit support for CE marking Technical Documentation under MDD/MDR.
- Review and approve device labeling and marketing materials for compliance with applicable regulations and claims.
- Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
- Author regulatory documents under minimal supervision and serve as in-house regulatory expert to internal and external stakeholders.
- Monitor proposed and current US and EU regulations and guidance and advise on the impact of such regulations.
- Provide technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams.
- Identify and evaluate regulatory processes and systems for improvements ensuring compliance.
- Support Post Market Surveillance activities, including the Clinical Evaluation Report (CER) and Periodic Safety Update Report (PSUR).
- Assist with customer complaints/CAPA system.
- Maintain and increase professional and technical knowledge by on-the-job training, attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
- Perform special projects and other duties as assigned.
Required- Bachelor's degree in Engineering, Science or Regulatory Affairs.
- A minimum of seven years' experience in an FDA regulated industry required, preferably with medical devices.
- Experience supporting FDA inspections and Notified Body audits.
- Strong working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
- Strong working knowledge of US and EU regulations that affect Class II and IIa medical devices.
- Experience working on cross functional projects.
Bonus- RAPS Certification (RAC) experience.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Excellent English communication skills (both written and verbal), including negotiating and relationship management skills.
- Excellent planning and organizational skills.
- Excellent analytical thinking and problem solving skills.
- Ability to support multiple projects and balance priorities.
- Ability to manage competing priorities in a fast-paced environment.
- Tech savvy: proficiency in Microsoft Office applications, quality management systems such as Qualio or MasterControl, and in mobile/cloud resources; comfortable learning new technical systems as needed such as Box, Zoom, Slack, Smartsheet, and Concur, and working in a paperless environment. Ability to overcome barriers and operate in a virtual organization.
- Travel (Distributed Workforce) - Approximately 5% of time will be spent traveling for team meetings, conferences, or meetings.
- Physical Demand - While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Physical effort required by handling objects of 25 pounds or more occasionally and/or up to 10 pounds frequently. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer. The physical demands 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.
- Mental Demand - Moderate to high degree of concentration due to volume, complexity, and/or "pressure" of work. Ability to make critical thinking skills decisions under pressure.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of all employees assigned to this position. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.In addition to offering a great culture and work environment, Vertos also offers the following benefits:Health Insurance- Medical
- Dental
- Vision
- Basic Life and AD&D
- Supplemental Life & AD&D
- Long-Term Disability
- Health Care and Dependent Care Flexible Spending Accounts (FSAs)
- Health Savings Accounts (HSAs) with employer contribution
Paid Time Off- Paid Time Off
- Paid Holidays
- Jury/Witness Duty Leave
- Bereavement Leave
- Parental Leave Salary Continuation
- Short-Term Disability Salary Continuation
Other Benefits- 401(k) Retirement Savings Plan with employer match
- Employee Assistance Program
- Voluntary Accident, Critical Illness, Hospital Indemnity and Legal
- Access to BenefitHUB discounts for 200,000 vendors
Pay Range: $106,000 - $150,000 per year Apply for this Position
Vertos is an equal employment opportunity workplace committed to pursuing and hiring a diverse workforce. We strive to grow our team with highly skilled people who share our culture and values. All qualified applicants will receive consideration for employment without regards to sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender identity, physical & mental disability, medical condition, genetic information, veteran status, or any other basis protected by federal, state or local law. - 10 Days Ago
Regulatory Affairs Specialist II
- YOH Services LLC
-
Irvine, CA
FULL_TIME
- Regulatory Affairs Specialist II Category: Life Science Employment Type: Contract Reference: BH-372435 Regulatory Affairs Specialist II needed for a contract opportunity with Yoh Scientific's client l...
- Just Posted
Regulatory Affairs Specialist II
- Synergy Solutions
-
Irvine, CA
CONTRACTOR
- 1 year contract with possible extension and conversion to permanent employment Hybrid position- 3 days on site T, TH and tbd. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activiti...
- 4 Days Ago
Software Regulatory Affairs Specialist
- Nihon Kohden
-
Irvine, CA
FULL_TIME
- The Software Regulatory Affairs Specialist is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for th...
- 5 Days Ago
Regulatory Affairs Specialist II
- Advantage Technical
-
Irvine, CA
FULL_TIME
- Advantage Technical is seeking a Regulatory Affairs Specialist for our client in Irvine, CA. This position is Hybrid - Monday - Wednesday - Friday on-site and Tuesday - Thursday remote. Support the EU...
- 6 Days Ago
Regulatory Affairs specialist
- Katalyst Healthcares & Life Sciences
-
Irvine, CA
FULL_TIME
- Responsibilities Prepare, submit, and maintain product registration dossiers, label amendments and related activities in United States. Maintain regular contact with other departments and registration...
- 8 Days Ago
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0 Regulatory Affairs Specialist jobs found in Huntington Beach, CA area
Principal Regulatory Affairs Specialist
- Philips
-
Orange, CA
- Job Title Principal Regulatory Affairs Specialist Job Description Principal Regulatory Affairs Specialist (U.S. Hub base...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Medtronic, plc
-
Northridge, CA
- Partner with Geography RA to plan, develop and execute global regulatory activities necessary to obtain and maintain reg...
- 4/18/2024 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...
- 4/17/2024 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...
- 4/17/2024 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...
- 4/17/2024 12:00:00 AM
Regulatory Affairs Specialist
- Nihon Kohden America
-
Irvine, CA
- The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining a...
- 4/16/2024 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....
- 4/16/2024 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: Ma...
- 4/16/2024 12:00:00 AM
About Huntington Beach, California
Huntington Beach is a seaside city in Orange County in Southern California. The city is named after American businessman Henry E. Huntington. The population was 189,992 during the 2010 census, making it the most populous beach city in Orange County and the seventh most populous city in the Los Angeles-Long Beach-Anaheim, CA Metropolitan Statistical Area.[citation needed] Its estimated 2014 population was 200,809. It is bordered by Bolsa Chica Basin State Marine Conservation Area on the west, the Pacific Ocean on the southwest, by Seal Beach on the northwest, by Westminster on the north, by Fou...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$84,005 to $112,580
Huntington Beach, California area prices
were up 3.0% from a year ago
were up 3.0% 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