Regulatory Affairs Specialist Jobs in Berkeley, 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.
- Alameda, CA (6 miles from Berkeley, CA)
- 4 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 4 days ago
The Opportunity As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business...
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 12 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 12 days ago
The Opportunity As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including...
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 45+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 45+ 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 (6 miles from Berkeley, CA)
- 1 day ago
- Alameda, CA (6 miles from Berkeley, CA)
- 1 day 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 (10 miles from Berkeley, CA)
- 3 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 3 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 (6 miles from Berkeley, CA)
- 3 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 3 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 (10 miles from Berkeley, CA)
- 5 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 5 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 (6 miles from Berkeley, CA)
- 5 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 5 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 (10 miles from Berkeley, CA)
- 8 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 8 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 (10 miles from Berkeley, CA)
- 9 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 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 (10 miles from Berkeley, CA)
- 9 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 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 (16 miles from Berkeley, CA)
- 23 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 23 days ago
We are seeking a Life Sciences-Regulatory Affairs Specialist for an assignment in South San Francisco California....
Regulatory Affairs Specialist 1 825405
- Hercules, CA (9 miles from Berkeley, CA)
- 30+ days ago
- Hercules, CA (9 miles from Berkeley, CA)
- 30+ days ago
Understanding of scientific reports, risk management, Quality Systems Let our local Helpmates recruiters help you reach your career goals....
IACUP Training & Compliance Analyst
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
IACUP Training & Compliance Analyst 4.1 4.1 out of 5 stars 500 Parnassus Ave, San Francisco, CA 94143 Under the general direction of the Executive Director, the IACUP Training & Compliance Analyst...
IACUP Training & Compliance Analyst University of California San Francisco
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
Under the general direction of the Executive Director, the IACUP Training & Compliance Analyst works closely with the IACUC, Office of Ethics and Compliance management, Office of Research...
Demographic Data for Berkeley, CA
Moving to Berkeley, CA? Find some basic demographic data about Berkeley, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Berkeley, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Berkeley, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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