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.
Senior Regulatory Affairs Specialist - Urology
- Valencia, CA (18 miles from Simi Valley, CA)
- 10 hours ago
- Valencia, CA (18 miles from Simi Valley, CA)
- 10 hours ago
, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies....
Regulatory Affairs Specialist III - Urology
- Valencia, CA (18 miles from Simi Valley, CA)
- 10 hours ago
- Valencia, CA (18 miles from Simi Valley, CA)
- 10 hours 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 - Food Manufacturing
- San Fernando, CA (20 miles from Simi Valley, CA)
- 1 day ago
- San Fernando, CA (20 miles from Simi Valley, CA)
- 1 day ago
an experienced Regulatory Affairs Specialist to join our growing team and lead regulatory compliance initiatives for our diverse portfolio of food, flavor, and beverage products....
Regulatory Affairs Specialist - Valencia, CA
- Valencia, CA (18 miles from Simi Valley, CA)
- 13 days ago
- Valencia, CA (18 miles from Simi Valley, CA)
- 13 days ago
Regulatory Affairs Specialist - Valencia, CA** Kelly Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1 year) at a biotech company in Valencia, CA,...
Regulatory Affairs Specialist III Food & Bev
- San Fernando, CA (20 miles from Simi Valley, CA)
- 24 days ago
- San Fernando, CA (20 miles from Simi Valley, CA)
- 24 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)
- 90+ days ago
- Westlake Village, CA (7 miles from Simi Valley, CA)
- 90+ days ago
Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures....
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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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