Regulatory Affairs Specialist Jobs in Thousand Oaks, 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
- 3 days ago
- Thousand Oaks, CA
- 3 days ago
We are seeking a Life Sciences-Regulatory Affairs Specialist for an assignment in Thousand Oaks California....
Regulatory Affairs Specialist II
- Valencia, CA (23 miles from Thousand Oaks, CA)
- 6 days ago
- Valencia, CA (23 miles from Thousand Oaks, CA)
- 6 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...
Functional knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations....
- Westlake Village, CA (4 miles from Thousand Oaks, CA)
- 23 days ago
- Westlake Village, CA (4 miles from Thousand Oaks, 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 (23 miles from Thousand Oaks, CA)
- 45+ days ago
- Valencia, CA (23 miles from Thousand Oaks, CA)
- 45+ days ago
The Senior Regulatory Affairs Specialist will be a part of the Neuromodulation Regulatory Affairs team....
- Camarillo, CA (10 miles from Thousand Oaks, CA)
- 60+ days ago
- Camarillo, CA (10 miles from Thousand Oaks, 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 Thousand Oaks, CA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Thousand Oaks, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Thousand Oaks, 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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