Regulatory Affairs Specialist Jobs in Foothill Ranch, 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.
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 1 day ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 1 day ago
15345 Barranca Pkwy, Irvine, California 92618Full-time Qualifications Strong communication, customer service, time management and organizational skills. Bachelor's degree or equivalent experience...
Global Internal Audit & Compliance Analyst
- Newport Beach, CA (12 miles from Foothill Ranch, CA)
- 2 days ago
- Newport Beach, CA (12 miles from Foothill Ranch, CA)
- 2 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 (5 miles from Foothill Ranch, CA)
- 4 days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 4 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...
Human Resources Policy & Compliance Analyst
- Pomona, CA (21 miles from Foothill Ranch, CA)
- 9 days ago
- Pomona, CA (21 miles from Foothill Ranch, CA)
- 9 days ago
: HR Policy Under supervision of the Director of HR Policy & Compliance, assist in compiling, implementing, administering, interpreting, communicating, explaining, and clarifying CSU and campus...
HR Policy & Compliance Analyst
- Pomona, CA (21 miles from Foothill Ranch, CA)
- 15 days ago
- Pomona, CA (21 miles from Foothill Ranch, CA)
- 15 days ago
Type of Appointment: Full Time, At-Will Job Classification: Confidential Administrative Support I Anticipated Hiring Range: $4,261 - $5,900 per month Work Schedule: Monday Friday 8:00 a.m. - 5:00...
Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 18 days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 18 days ago
Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD...
Regulatory Affairs Specialist, Sr.
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 20 days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 20 days ago
Regulatory Affairs Specialist, Sr....
Sr. Specialist, Regulatory Affairs
- Aliso Viejo, CA (8 miles from Foothill Ranch, CA)
- 20 days ago
- Aliso Viejo, CA (8 miles from Foothill Ranch, CA)
- 20 days ago
. + Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout...
Compliance Analyst - Provider Compliance
- Orange, CA (11 miles from Foothill Ranch, CA)
- 30+ days ago
- Orange, CA (11 miles from Foothill Ranch, CA)
- 30+ days ago
Provides support with Internal Audit Department activities relating to provider compliance....
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 30+ days ago
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 30+ days ago
As a Senior Regulatory Affairs Specialist within Alcon's Digital Health Quality and Regulatory Affairs (QRA) team, you will be trusted to ensure compliance with regulatory requirements for software...
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
Senior Compliance Analyst Description POSITION DESCRIPTION: EnFin is a financial services company that provides financing for residential solar PV and energy efficiency upgrades, backed by the PV...
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 45+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 45+ days ago
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report....
Regulatory Compliance Specialist
- Brea, CA (19 miles from Foothill Ranch, CA)
- 45+ days ago
- Brea, CA (19 miles from Foothill Ranch, CA)
- 45+ days ago
Employment Type: Salaried Work Arrangement: Remote Position Summary: We are seeking a Regulatory Compliance Specialist to join our team of food regulatory professionals, to provide expertise in...
Senior Specialist, Regulatory Affairs THV
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 90+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 90+ days ago
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
Senior Specialist, Regulatory Affairs
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 90+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 90+ days ago
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we...
Demographic Data for Foothill Ranch, CA
Moving to Foothill Ranch, CA? Find some basic demographic data about Foothill Ranch, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Foothill Ranch, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Foothill Ranch, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Technical Writing
- Product Development
- Systems Applications & Products
- Engineering
- Risk Management
- Strategy Development
- Analytical Skills
- Process Improvement
- Military Background
- Auditing
- Implementation
- Investigation
- Verbal Communication
- Written Communication
- Data Analysis
- Documentation
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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