Regulatory Affairs Specialist Jobs in Irvine, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Sr. Specialist, Regulatory Affairs
- Metagenics
- Aliso Viejo, CA (10 miles from Irvine, CA)
- 1 day ago
- Aliso Viejo, CA (10 miles from Irvine, CA)
- 1 day ago
Prior experience operating in a technical environment, knowledge of quality management principles and systems, understanding of manufacturing and packaging in a pharmaceutical environment International...
In PersonSpecialist, Regulatory Affairs Surgical
- Edwards Lifesciences
- Irvine, CA
- 5 days ago
- Irvine, CA
- 5 days ago
May interact 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) Provide...
In PersonEarned Value Compliance Analyst (Subject Matter Expert)
- Boeing
- Huntington Beach, CA (14 miles from Irvine, CA)
- 6 days ago
- Huntington Beach, CA (14 miles from Irvine, CA)
- 6 days ago
Job Description At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive,...
Hybrid- Paramount Residential Mortgage Group
- Corona, CA (13 miles from Irvine, CA)
- 13 days ago
- Corona, CA (13 miles from Irvine, CA)
- 13 days ago
Prepare and maintain exam-ready loan files and support documentation for internal audits, regulatory exams, and third-party reviews....
In PersonSenior Security Governance, Risk and Compliance Analyst
- RAVE Aerospace
- Brea, CA (14 miles from Irvine, CA)
- 16 days ago
- Brea, CA (14 miles from Irvine, CA)
- 16 days ago
Job Summary: The Senior Security Governance, Risk and Compliance Analyst will lead the Information Security Governance, Risk and Compliance (GRC) function. The Senior Security GRC Analyst will...
In PersonPrincipal Regulatory Affairs Specialist - Cardiac Ablation
- Biotronik
- Tustin, CA (4 miles from Irvine, CA)
- 18 days ago
- Tustin, CA (4 miles from Irvine, CA)
- 18 days ago
Principal Regulatory Affairs Specialist - Cardiac Ablation BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology...
Hybrid Full TimeAssociate Labeling Specialist Regulatory Affairs
- Applied Medical
- Rancho Santa Margarita, CA (11 miles from Irvine, CA)
- 30+ days ago
- Rancho Santa Margarita, CA (11 miles from Irvine, CA)
- 30+ days ago
Familiarity with Quality Systems Regulations (QSRs), Good Manufacturing Practices (GMPs), and ISO standards for medical devices....
In PersonSenior Regulatory Affairs Specialist, Post Market
- Kelly Services
- Irvine, CA
- 30+ days ago
- Irvine, CA
- 30+ days ago
Senior Regulatory Affairs Specialist, Post Market Apply Now Applied To save a job sign in or get started Job ID: 10212058 Posted today Back Irvine, CA, US Scientific Bachelors Degree Full Time, Direct...
In PersonQuality Assurance/Regulatory Affairs Specialist MENTAL, PHYSICAL AND VISUAL DEMANDS: Position entails some travel. Ability to work under pressure of deadlines is necessary....
In PersonSupply Chain Compliance Analyst
- ANDURIL INDUSTRIES
- Costa Mesa, CA (10 miles from Irvine, CA)
- 30+ days ago
- Costa Mesa, CA (10 miles from Irvine, CA)
- 30+ days ago
This role translates complex regulatory requirements-FAR/DFARS, ITAR, export controls, and customer flow-downs-into clear, executable processes that withstand internal audits, customer scrutiny, and...
In Person- Assa Abloy
- Lake Forest, CA (5 miles from Irvine, CA)
- 30+ days ago
- Lake Forest, CA (5 miles from Irvine, CA)
- 30+ days ago
The Trade Compliance Analyst supports and executes the companys import trade compliance program, with responsibility for determining product classifications, country of origin, and tariff...
In PersonSenior Specialist, Regulatory Affairs Operations
- JENAVALVE TECHNOLOGY INC
- Irvine, CA
- 30+ days ago
- Irvine, CA
- 30+ days ago
Working knowledge of quality systems and relationship to business. Ability to work in a fast-paced, technically challenging environment where drive is critical to success....
In Person- Paramount Residential Mortgage Group
- Corona, CA (13 miles from Irvine, CA)
- 30+ days ago
- Corona, CA (13 miles from Irvine, CA)
- 30+ days ago
Prepare and maintain exam-ready loan files and support documentation for internal audits, regulatory exams, and third-party reviews....
RemoteRegulatory Affairs Associate I#26-11111 $33.03-$35.16 per hour Irvine, CA All On-site Job Description Job Description: Contributions will include: generate graphs and figures for journal...
In Person- Envista
- Pomona, CA (17 miles from Irvine, CA)
- 45+ days ago
- Pomona, CA (17 miles from Irvine, CA)
- 45+ days ago
Support internal audits, inspections, and regulatory assessments....
In PersonDemographic Data for Irvine, CA
Moving to Irvine, CA? Find some basic demographic data about Irvine, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Irvine, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Irvine, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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