Regulatory Affairs Specialist Jobs in Temecula, 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.
CMC Regulatory Affairs Specialist
- Carlsbad, CA (24 miles from Temecula, CA)
- 15 days ago
- Carlsbad, CA (24 miles from Temecula, CA)
- 15 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....
Senior Specialist, Regulatory Affairs
- Carlsbad, CA (24 miles from Temecula, CA)
- 26 days ago
- Carlsbad, CA (24 miles from Temecula, CA)
- 26 days ago
CFR 820 (Design Controls) and ISO 13485 for Quality Management Systems to ensure regulatory compliance across product lifecycle stages; 4) 2 years of experience applying ISO 14971 for risk management...
- Carlsbad, CA (24 miles from Temecula, CA)
- 27 days ago
- Carlsbad, CA (24 miles from Temecula, CA)
- 27 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 (24 miles from Temecula, CA)
- 30+ days ago
- Carlsbad, CA (24 miles from Temecula, CA)
- 30+ 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 Temecula, CA
Moving to Temecula, CA? Find some basic demographic data about Temecula, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Temecula, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Temecula, 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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