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.
- Pleasanton, CA (21 miles from Oakland, CA)
- 1 day ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 1 day 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)
- 1 day ago
- San Francisco, CA (11 miles from Oakland, CA)
- 1 day 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)
- 2 days ago
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 2 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)
- 2 days ago
- Pleasant Hill, CA (14 miles from Oakland, CA)
- 2 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)
- 3 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 3 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)....
Compliance analyst with Hitrust experience
- Menlo Park, CA (22 miles from Oakland, CA)
- 3 days ago
- Menlo Park, CA (22 miles from Oakland, CA)
- 3 days ago
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
- Emeryville, CA (5 miles from Oakland, CA)
- 3 days ago
- Emeryville, CA (5 miles from Oakland, CA)
- 3 days ago
IT Compliance Location : Emeryville, CA Duration : 12+ months Contract Job Description: 1. Ensures IT operates in compliance to GxP regulations & ensures compliance objectives are demonstrably met...
Senior Regulatory Affairs Specialist
- Redwood City, CA (21 miles from Oakland, CA)
- 3 days ago
- Redwood City, CA (21 miles from Oakland, CA)
- 3 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)
- 14 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 14 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...
Principal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (3 miles from Oakland, CA)
- 14 days ago
- Alameda, CA (3 miles from Oakland, CA)
- 14 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)....
- Pleasanton, CA (21 miles from Oakland, CA)
- 15 days ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 15 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)...
Principal Regulatory Affairs Specialist (Business Partnerships).
- Alameda, CA (3 miles from Oakland, CA)
- 17 days ago
- Alameda, CA (3 miles from Oakland, CA)
- 17 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)....
Compliance Analyst (2 Positions)
- San Francisco, CA (11 miles from Oakland, CA)
- 18 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 18 days ago
THIS JOB POSTING WILL REMAIN OPEN UNTIL A QUALIFIED POOL OF APPLICANTS IS ESTABLISHED AND MAY CLOSE AT ANY TIME IF YOU ARE INTERESTED, PLEASE APPLY IMMEDIATELY A resume and cover letter are not...
- Walnut Creek, CA (10 miles from Oakland, CA)
- 19 days ago
- Walnut Creek, CA (10 miles from Oakland, CA)
- 19 days ago
Location: Menlo Park, CA; Rancho Cucamonga, CA; or Walnut Creek, CA Work Arrangement: In Office or Hybrid Typical Day in the Life A typical day as a Payroll Compliance Analyst (Associate) might...
- San Francisco, CA (11 miles from Oakland, CA)
- 20 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 20 days ago
Varo is an entirely new kind of bank. All digital, mission-driven, FDIC insured and designed for the way our customers live their lives. A bank for all of us. Varo is a next-generation bank built...
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
- 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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