Director of Regulatory Affairs Jobs in San Diego, 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.
Director, Regulatory Affairs City : San Diego State : CA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking a Director, Regulatory Affairs in San Diego, CA....
Job Title: Director, Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt Department: Finance ID: Regulatory Affairs 2601-Q125-12 Profoundly Improve People's...
The Opportunity This position, Associate Director Regulatory Affairs, works out of our San Diego, CA location in the Infectious Diseases Division....
Job Overview The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies....
Senior Director Regulatory Affairs, Dispensing
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Dispensing RA organization under the Medication Management Business Unit....
FDA regulations, CLIA requirements, EU IVDR, ISO 13485, and other global regulatory standards relevant to IVDs. RAC certification preferred (U.S., Global, or EU)....
Manager, Regulatory Affairs - Hybrid UC San Diego Health - 4.1 San Diego, CA Job Details $45.21 - $84.67 an hour 22 hours ago Qualifications Management Clinical research NRP Certification 5 years...
Senior Director Regulatory Affairs (Dispensing and Pharmacy Automation Platforms)
- San Diego, CA
- 60+ days ago
- San Diego, CA
- 60+ days ago
Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Dispensing and Pharmacy Automation RA organization under the Medication Management Business Unit....
This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions....
Demographic Data for San Diego, CA
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Salary for Director of Regulatory Affairs Jobs in San Diego, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in San Diego, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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