Regulatory Affairs Specialist Jobs in California
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.
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Sr Principal International Trade Compliance Analyst
- Redondo Beach, CA
- 2 hours ago
- Redondo Beach, CA
- 2 hours ago
RELOCATION ASSISTANCE: No relocation assistance availableCLEARANCE TYPE: NoneTRAVEL: Yes, 10% of the Time \*Description\* At Northrop Grumman, our employees have incredible opportunities to work...
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, CA
- 3 hours ago
- Lake Forest, CA
- 3 hours 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...
POSITION SUMMARY At Nordic Naturals, we take pride in crafting foundational nutrients to help people all over the world live healthy lives. Our mission is to give people, pets, and families the...
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
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....
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...
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
Compliance & Regulatory Affairs Specialist Corporate position responsible for ensuring artwork and advertisements are legally compliant for all of Niagara, LLC....
About Marvell Marvells semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier...
We are seeking a Life Sciences-Regulatory Affairs Specialist for an assignment in Thousand Oaks California....
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
Insight Global is looking for a compliance analyst to work remote for an enterprise cloud and security organization. This person will be responsible for ensuring annual cloud and security...
Sr. Security Governance, Risk & Compliance Analyst - Paze
- San Francisco, CA
- 2 days ago
- San Francisco, CA
- 2 days ago
Act as Point of Contact and Project Manager for Information Technology and Security focused external and internal audits and assessments (SOC-2, GLBA, FISMA, PCI DSS, FFIEC, & others)....
Primary Responsibilities: Develop and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents....
Demographic Data for California
Moving to California? Find some basic demographic data about California below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in California
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in California offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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