Regulatory Affairs Specialist Jobs in San Rafael, 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.
About Us: In a rapidly changing world, HUB advises businesses and individuals on how to prepare for the unexpected. As one of the worlds' largest insurance brokers, our focus is dedicated to...
- Oakland, CA (20 miles from San Rafael, CA)
- 8 days ago
- Oakland, CA (20 miles from San Rafael, CA)
- 8 days ago
Compliance Analyst Oakland, CA Approximate contract length is 5+ Months ONLY SUBMIT CANDIDATES CURRENTLY RESIDING IN BAY AREA/NEAR WORK LOCATION-OAKLAND. ASSIGMENT IS HYBRID AND REQUIRED...
Compliance Analyst/ Senior Compliance Consultant
- Oakland, CA (20 miles from San Rafael, CA)
- 8 days ago
- Oakland, CA (20 miles from San Rafael, CA)
- 8 days ago
**********LOCAL CANDIDATES ONLY***NO C2C*************** Title Compliance Analyst Location - Oakland, CA (hybrid) Pay Range: 60k -77k/annum Job id - 3312 Description: LOOKING FOR CANDIDATES...
Principal Regulatory Affairs Specialist (Business Partnerships).
- Alameda, CA (18 miles from San Rafael, CA)
- 13 days ago
- Alameda, CA (18 miles from San Rafael, CA)
- 13 days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
- Alameda, CA (18 miles from San Rafael, CA)
- 18 days ago
- Alameda, CA (18 miles from San Rafael, CA)
- 18 days ago
Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Sr. Privacy Regulatory Compliance Analyst
- San Francisco, CA (14 miles from San Rafael, CA)
- 20 days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 20 days ago
Sr. Privacy Regulatory Compliance Analyst Delta Dental of California $71,400 - $149,500 dental insurance, paid time off, paid holidays, tuition reimbursement, 401(k), employee discount United...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (18 miles from San Rafael, CA)
- 20 days ago
- Alameda, CA (18 miles from San Rafael, CA)
- 20 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Senior Technology Compliance Analyst
- San Francisco, CA (14 miles from San Rafael, CA)
- 22 days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 22 days ago
Posting Open Date: June 10, 2025 Anticipated Posting Close Date*: July 10, 2025 Job posting may close early due to the volume of applicants. Sr. Technology Compliance Analyst As a Technology...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (18 miles from San Rafael, CA)
- 22 days ago
- Alameda, CA (18 miles from San Rafael, CA)
- 22 days ago
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location...
- San Francisco, CA (14 miles from San Rafael, CA)
- 25 days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 25 days ago
Sanctions Compliance Analyst Morrison & Foerster, LLP - 3.6 San Francisco, CA Job Details Full-time $69,000 - $118,000 a year 23 hours ago Benefits Profit sharing Wellness program Paid holidays...
- San Francisco, CA (14 miles from San Rafael, CA)
- 26 days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 26 days ago
Compliance Analyst Norton Rose Fulbright parental leave, paid time off, 401(k) United States, California, San Francisco 555 California Street (Show on map) Jun 04, 2025 Job Description We are a...
Regulatory Affairs Associate Director
- San Francisco, CA (14 miles from San Rafael, CA)
- 27 days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 27 days ago
THE COMPANY 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal...
Regulatory Affairs Specialist - Life Sciences
- South San Francisco, CA (22 miles from San Rafael, CA)
- 30+ days ago
- South San Francisco, CA (22 miles from San Rafael, CA)
- 30+ days ago
We are seeking a Life Sciences-Regulatory Affairs Specialist for an assignment in South San Francisco California....
Reliability Compliance Analyst CIP
- San Francisco, CA (14 miles from San Rafael, CA)
- 60+ days ago
- San Francisco, CA (14 miles from San Rafael, CA)
- 60+ days ago
Overview COMPANY OVERVIEW Pattern Energy is a leading renewable energy company that develops, constructs, owns, and operates high-quality wind and solar generation, transmission, and energy...
Principal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (18 miles from San Rafael, CA)
- 60+ days ago
- Alameda, CA (18 miles from San Rafael, CA)
- 60+ days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
Demographic Data for San Rafael, CA
Moving to San Rafael, CA? Find some basic demographic data about San Rafael, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Rafael, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Rafael, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Writing Skills
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Critical Thinking
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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