Regulatory Affairs Specialist Jobs in Benicia, 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 (23 miles from Benicia, CA)
- 5 days ago
- Alameda, CA (23 miles from Benicia, CA)
- 5 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 (23 miles from Benicia, CA)
- 13 days ago
- Alameda, CA (23 miles from Benicia, CA)
- 13 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 (23 miles from Benicia, CA)
- 45+ days ago
- Alameda, CA (23 miles from Benicia, 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 (23 miles from Benicia, CA)
- 2 days ago
- Alameda, CA (23 miles from Benicia, CA)
- 2 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...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (23 miles from Benicia, CA)
- 4 days ago
- Alameda, CA (23 miles from Benicia, CA)
- 4 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 Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (23 miles from Benicia, CA)
- 5 days ago
- Alameda, CA (23 miles from Benicia, 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...
- Fairfield, CA (14 miles from Benicia, CA)
- 30+ days ago
- Fairfield, CA (14 miles from Benicia, CA)
- 30+ days ago
Job Type Full-time Description Westamerica is among the largest commercial banks headquartered in California. We are looking for outstanding people to join our winning team. We reached our current...
- Pleasant Hill, CA (10 miles from Benicia, CA)
- 45+ days ago
- Pleasant Hill, CA (10 miles from Benicia, CA)
- 45+ days ago
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
Regulatory Affairs Specialist II
- Alameda, CA (23 miles from Benicia, CA)
- 90+ days ago
- Alameda, CA (23 miles from Benicia, CA)
- 90+ days ago
System regulations (ISO 13485), Design Control, and regional Regulatory requirements....
Demographic Data for Benicia, CA
Moving to Benicia, CA? Find some basic demographic data about Benicia, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Benicia, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Benicia, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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
- Interpersonal Skills
- 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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