Regulatory Affairs Specialist Jobs in Simi Valley, 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.
Regulatory Affairs Specialist Life Sciences
- Thousand Oaks, CA (9 miles from Simi Valley, CA)
- 3 days ago
- Thousand Oaks, CA (9 miles from Simi Valley, CA)
- 3 days ago
We are seeking a Life Sciences-Regulatory Affairs Specialist for an assignment in Thousand Oaks California....
Regulatory Affairs Specialist II
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 4 days ago
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 4 days ago
About the role: The Regulatory Affairs Specialist II will be a part of the Neuromodulation Regulatory Affairs team and will support the regulatory submission activities to obtain and maintain approvals...
- Thousand Oaks, CA (9 miles from Simi Valley, CA)
- 6 days ago
- Thousand Oaks, CA (9 miles from Simi Valley, CA)
- 6 days ago
Functional knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations....
- San Fernando, CA (20 miles from Simi Valley, CA)
- 13 days ago
- San Fernando, CA (20 miles from Simi Valley, CA)
- 13 days ago
Regulatory Affairs Specialist Regulatory Affairs San Fernando Valley, CA, US Pay Rate Low: 31 | Pay Rate High: 35 A leading company in the food and beverage industry is seeking a Regulatory Affairs...
Regulatory Affairs Specialist III - Food & Bev
- San Fernando, CA (20 miles from Simi Valley, CA)
- 15 days ago
- San Fernando, CA (20 miles from Simi Valley, CA)
- 15 days ago
Affairs Specialist III - Food & Bev Kelly Science & Clinical is seeking a Regulatory Affairs Specialist III for a temp-to-hire position at a leading company in the food, flavor, and beverage industry...
Regulatory Affairs Specialist III Food & Bev
- San Fernando, CA (20 miles from Simi Valley, CA)
- 17 days ago
- San Fernando, CA (20 miles from Simi Valley, CA)
- 17 days ago
Regulatory Affairs Specialist III Food & Bev Kelly Science & Clinical is seeking a Regulatory Affairs Specialist III for a temp-to-hire position at a leading company in the food, flavor, and beverage...
- Westlake Village, CA (7 miles from Simi Valley, CA)
- 23 days ago
- Westlake Village, CA (7 miles from Simi Valley, CA)
- 23 days ago
Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures....
Senior Regulatory Affairs Specialist
- Valencia, CA (18 miles from Simi Valley, CA)
- 30+ days ago
- Valencia, CA (18 miles from Simi Valley, CA)
- 30+ days ago
The Senior Regulatory Affairs Specialist will be a part of the Neuromodulation Regulatory Affairs team....
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 30+ days ago
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 30+ days ago
Quality Management System and Regulatory Affairs Program: Assists in maintaining an ISO 9001, CMDR, FDA (21 CFR 820), FDB, NRC 10 CFR 50 Appendix B, DOT (49 CFR) / IAEA, BIS (Bureau of Industry & Security...
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 45+ days ago
- Santa Clarita, CA (19 miles from Simi Valley, CA)
- 45+ days ago
Company: Kelly Services Location: Santa Clarita, CA Career Level: Associate Industries: Recruitment Agency, Staffing, Job Board Description Regulatory Affairs Specialist - Valencia, CA Kelly Science...
- Camarillo, CA (16 miles from Simi Valley, CA)
- 60+ days ago
- Camarillo, CA (16 miles from Simi Valley, CA)
- 60+ days ago
Location: Camarillo, CA Our Team: At Semtech, our Quality Team is the heartbeat of our organization, ensuring that every customer request is met with precision and care. We pride ourselves on our...
Demographic Data for Simi Valley, CA
Moving to Simi Valley, CA? Find some basic demographic data about Simi Valley, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Simi Valley, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Simi Valley, 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
- 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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