Regulatory Affairs Specialist Jobs in San Clemente, 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
- Aliso Viejo, CA (17 miles from San Clemente, CA)
- 4 days ago
- Aliso Viejo, CA (17 miles from San Clemente, CA)
- 4 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...
Regulatory Affairs Specialist II
- Lake Forest, CA (17 miles from San Clemente, CA)
- 5 days ago
- Lake Forest, CA (17 miles from San Clemente, CA)
- 5 days ago
Lake Forest : J55 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive...
Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring
- Laguna Beach, CA (17 miles from San Clemente, CA)
- 16 days ago
- Laguna Beach, CA (17 miles from San Clemente, CA)
- 16 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...
Associate Labeling Specialist Regulatory Affairs
- Rancho Santa Margarita, CA (16 miles from San Clemente, CA)
- 25 days ago
- Rancho Santa Margarita, CA (16 miles from San Clemente, CA)
- 25 days ago
Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines....
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, CA (17 miles from San Clemente, CA)
- 27 days ago
- Lake Forest, CA (17 miles from San Clemente, CA)
- 27 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...
CMC Regulatory Affairs Specialist
- Carlsbad, CA (21 miles from San Clemente, CA)
- 28 days ago
- Carlsbad, CA (21 miles from San Clemente, CA)
- 28 days ago
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As part of Siemens Healthineers, PETNET is at the forefront of radiopharmaceuticals and molecular imaging....
- Carlsbad, CA (21 miles from San Clemente, CA)
- 30+ days ago
- Carlsbad, CA (21 miles from San Clemente, CA)
- 30+ days ago
The Regulatory Affairs Specialist will support the company's regulatory compliance efforts, ensuring that new and existing products meet global regulatory requirements....
Sr. Regulatory Affairs Associate
- Carlsbad, CA (21 miles from San Clemente, CA)
- 45+ days ago
- Carlsbad, CA (21 miles from San Clemente, CA)
- 45+ days ago
The Senior Regulatory Affairs Associate provides regulatory guidance to assists in the development and execution of effective regulatory affairs strategies and regulatory filings for product...
Demographic Data for San Clemente, CA
Moving to San Clemente, CA? Find some basic demographic data about San Clemente, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Clemente, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Clemente, 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
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- Document Management
- FDA Regulations
- Microsoft Visio
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Verbal Communication
- Written Communication
- Documentation
- Data Analysis
- 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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