Regulatory Affairs Specialist Jobs in San Luis Rey, 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
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 12 days ago
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 12 days ago
Provide regulatory support for quality system related changes i.e. ECOs, MCOs, NCMRs, SDRs, etc. Help drive process and compliance improvements activities....
Sr. Specialist, Regulatory Affairs
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 18 days ago
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 18 days ago
Expertise in ISO 13485, 21 CFR 820, MDSAP, and MDR regulations. Ability to analyze regulatory updates and provide proactive strategic solutions....
(Contract) Regulatory Affairs Specialist
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 28 days ago
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 28 days ago
Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups Represent regulatory on various projects supporting compliance Provide regulatory guidance to...
Sr. Regulatory Affairs Associate
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 90+ days ago
- Carlsbad, CA (11 miles from San Luis Rey, CA)
- 90+ 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...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Luis Rey, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Luis Rey, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Consulting
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Data Entry
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Multitasking
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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