Regulatory Affairs Specialist 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.
Primary Responsibilities: Develop and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents....
Staff Regulatory Affairs Specialist Advertising/Labeling (hybrid)
- San Diego, CA
- 4 days ago
- San Diego, CA
- 4 days ago
Job Overview As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical...
Company Description ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives...
- La Jolla, CA (10 miles from San Diego, CA)
- 11 days ago
- La Jolla, CA (10 miles from San Diego, CA)
- 11 days ago
Senior SOX Compliance Analyst Salary: $95120k Location: San Diego Hybrid (2 days on-site) Were working with a well-established and rapidly expanding biotechnology client in San Diego thats looking...
A top employer in the mortgage industry is looking for a Document Compliance Analyst to join their team in a fully remote role. This person will be responsible for ensuring compliance with...
Remote Work- La Jolla, CA (10 miles from San Diego, CA)
- 18 days ago
- La Jolla, CA (10 miles from San Diego, CA)
- 18 days ago
About Vaco: Vaco provides expert consulting, permanent placement, executive search, and strategic staffing for companies around the world, in the areas of accounting, finance, operations,...
Research Compliance Analyst (Administrative Analyst/Specialist, Non-Exempt)
- San Diego, CA
- 22 days ago
- San Diego, CA
- 22 days ago
Position Summary San Diego State Universitys Research Support Services is looking for a Research Compliance (Administrative Analyst/Specialist, Non-Exempt) to implement policies and procedures...
Senior SOX Compliance Analyst - Hybrid
- La Jolla, CA (10 miles from San Diego, CA)
- 45+ days ago
- La Jolla, CA (10 miles from San Diego, CA)
- 45+ days ago
About Vaco: Vaco provides expert consulting, permanent placement, executive search, and strategic staffing for companies around the world, in the areas of accounting, finance, operations,...
Regulatory Affairs Specialist II is responsible for developing strategies for worldwide regulatory approval to introduce new products to market, maintaining existing products, providing advice on regulatory...
Compliance Analyst, Associate 13026 Compliance Analyst, Associate 13026
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
Job Description: The candidate in this role will proactively support the administration of the Corporate Compliance Program by ensuring business transactions within all departments of our...
Regulatory Affairs Specialist role based in the United States of America is: $88,200 - $132,400....
Axos Bank Target Range: $70,000.00/Yr. - $80,000.00/Yr. Actual starting pay will vary based on factors including, but not limited to, geographic location, experience, skills, specialty, and...
Senior Specialist, Regulatory Affairs - Hybrid
- San Diego, CA
- 60+ days ago
- San Diego, CA
- 60+ days ago
Summary As Sr. Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software...
- Del Mar, CA (17 miles from San Diego, CA)
- 90+ days ago
- Del Mar, CA (17 miles from San Diego, CA)
- 90+ days ago
Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics...
Demographic Data for San Diego, CA
Moving to San Diego, CA? Find some basic demographic data about San Diego, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Diego, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Diego, 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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