Regulatory Affairs Specialist Jobs in Newport Coast, 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.
Job Description: Providing for loved ones, planning rewarding retirements, saving enough for whatever lies ahead our policyholders count on us to be there when it matters most. Its a big ask, but...
- Irvine, CA (11 miles from Newport Coast, CA)
- 7 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 7 days ago
auditing and benefits analysis Must have strong Excel skills, including experience with VLOOKUP, pivot tables, MATCH, and conditional formatting RESPONSIBILITIES: Administer and track daily job setup...
Remote IT Quality Assurance and Compliance, Analyst
- Anaheim, CA (16 miles from Newport Coast, CA)
- 11 days ago
- Anaheim, CA (16 miles from Newport Coast, CA)
- 11 days ago
Come join our amazing team and work remote from home! What youll do: Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring that...
Remote WorkSenior Regulatory Affairs Specialist - Urology
- Irvine, CA (11 miles from Newport Coast, CA)
- 16 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 16 days ago
, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies....
Regulatory Affairs Specialist III - Urology
- Irvine, CA (11 miles from Newport Coast, CA)
- 17 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 17 days ago
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio....
Regulatory Affairs Specialist II
- Cypress, CA (19 miles from Newport Coast, CA)
- 17 days ago
- Cypress, CA (19 miles from Newport Coast, CA)
- 17 days ago
Regulatory Affairs Specialist II Job Scope: The Regulatory Affairs Specialist II is responsible for developing and executing pre-market regulatory strategies to support global commercialization initiatives...
- Irvine, CA (11 miles from Newport Coast, CA)
- 19 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 19 days ago
Company: Kelly Services Location: Irvine, CA Career Level: Associate Industries: Recruitment Agency, Staffing, Job Board Description Job Title: Sr Analyst, Commercial Operations Department:...
Remote WorkCompliance Analyst - Audit & Certifications
- Irvine, CA (11 miles from Newport Coast, CA)
- 23 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 23 days ago
Compliance Analyst - Audit & Certifications Apply now SUMMARY We are seeking a detail-oriented and proactive Compliance Analyst to join our growing team. In this role, you will be instrumental in...
Senior Regulatory Affairs Specialist
- Irvine, CA (11 miles from Newport Coast, CA)
- 25 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 25 days ago
A Day in the Life The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio....
- Irvine, CA (11 miles from Newport Coast, CA)
- 27 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 27 days ago
Regulatory Affairs Specialist Contract Type: Contractor Location: Irvine Industry: Pharmaceuticals Contact Name: Flora Pollack Contact Phone: Date Published: 05-Jun-2025 Regulatory Affairs Specialist...
Regulatory and Compliance Analyst
- Irvine, CA (11 miles from Newport Coast, CA)
- 28 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 28 days ago
Regulatory and Compliance Analyst Rivian vision insurance United States, California, Irvine 14600 Myford Road (Show on map) Jun 05, 2025 About Rivian Rivian is on a mission to keep the world...
Principal Controls & Compliance Analyst (remote)
- Santa Ana, CA (10 miles from Newport Coast, CA)
- 30+ days ago
- Santa Ana, CA (10 miles from Newport Coast, CA)
- 30+ days ago
Principal Controls & Compliance Analyst (remote) First American Financial Corporation - 3.8 Santa Ana, CA Job Details $109,650 - $146,175 a year 11 hours ago Benefits Employee stock purchase plan...
Remote Work- Brea, CA (23 miles from Newport Coast, CA)
- 30+ days ago
- Brea, CA (23 miles from Newport Coast, CA)
- 30+ days ago
Works in partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance....
Global Internal Audit & Compliance Analyst
- Newport Beach, CA
- 30+ days ago
- Newport Beach, CA
- 30+ days ago
We are seeking a Global Internal Audit & Compliance Manager to lead American Vanguard's global internal audit and compliance function, ensuring full alignment with SOX requirements, regulatory expectations...
Sr Regulatory Operations Specialist
- Irvine, CA (11 miles from Newport Coast, CA)
- 30+ days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 30+ days ago
Close Sr Regulatory Operations Specialist Irvine, California Mechanical Engineering 258 days ago Apply Job Summary:Responsible for managing submission publishing, device listings, UDI data...
Demographic Data for Newport Coast, CA
Moving to Newport Coast, CA? Find some basic demographic data about Newport Coast, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newport Coast, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newport Coast, 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
- Vendor Management
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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