Regulatory Affairs Specialist Jobs in Oakland, 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.
Regulatory Affairs Coordinator
- Walnut Creek, CA (10 miles from Oakland, CA)
- 1 day ago
- Walnut Creek, CA (10 miles from Oakland, CA)
- 1 day ago
We are seeking a proactive and strategic Regulatory Affairs Coordinator to join our team and support both our Workers' Compensation and Healthcare lines of business. In this highly visible role,...
- San Francisco, CA (11 miles from Oakland, CA)
- 2 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 2 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkPrincipal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (3 miles from Oakland, CA)
- 2 days ago
- Alameda, CA (3 miles from Oakland, CA)
- 2 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)....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (21 miles from Oakland, CA)
- 3 days ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 3 days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
US Interchange Compliance Analyst
- Foster City, CA (15 miles from Oakland, CA)
- 6 days ago
- Foster City, CA (15 miles from Oakland, CA)
- 6 days ago
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and...
Compliance Analyst (HITRUST framework)
- Menlo Park, CA (22 miles from Oakland, CA)
- 6 days ago
- Menlo Park, CA (22 miles from Oakland, CA)
- 6 days ago
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
Product Regulatory Compliance Specialist
- Fremont, CA (19 miles from Oakland, CA)
- 7 days ago
- Fremont, CA (19 miles from Oakland, CA)
- 7 days ago
The Group Youll Be A Part Of In the Global Products Group, we are dedicated to excellence in the design and engineering of Lam's etch and deposition products. We drive innovation to ensure our...
- Pleasanton, CA (21 miles from Oakland, CA)
- 11 days ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 11 days ago
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
- San Francisco, CA (11 miles from Oakland, CA)
- 11 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 11 days ago
Senior Compliance Analyst Description POSITION DESCRIPTION: EnFin is a financial services company that provides financing for residential solar PV and energy efficiency upgrades, backed by the PV...
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 11 days ago
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 11 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...
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 12 days ago
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 12 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...
Sr. Security Governance, Risk & Compliance Analyst - Paze
- San Francisco, CA (11 miles from Oakland, CA)
- 12 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 12 days ago
Act as Point of Contact and Project Manager for Information Technology and Security focused external and internal audits and assessments (SOC-2, GLBA, FISMA, PCI DSS, FFIEC, & others)....
Senior Regulatory Affairs Specialist
- Redwood City, CA (21 miles from Oakland, CA)
- 13 days ago
- Redwood City, CA (21 miles from Oakland, CA)
- 13 days ago
Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory...
Regulatory Operations Specialist
- San Francisco, CA (11 miles from Oakland, CA)
- 23 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 23 days ago
About Anthropic Anthropic's mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a...
- Pleasanton, CA (21 miles from Oakland, CA)
- 24 days ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 24 days ago
IT SOX Compliance Analyst 1917 A leading enterprise software solutions company is seeking an IT SOX Compliance Analyst. The successful candidate will support audit and Sarbanes-Oxley (SOX)...
Demographic Data for Oakland, CA
Moving to Oakland, CA? Find some basic demographic data about Oakland, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Oakland, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Oakland, 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »