Regulatory Affairs Specialist Jobs in San Leandro, 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.
Reliability Compliance Analyst CIP
- San Francisco, CA (14 miles from San Leandro, CA)
- 1 day ago
- San Francisco, CA (14 miles from San Leandro, CA)
- 1 day 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...
Senior Regulatory Affairs Specialist, Ion
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 3 days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 3 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Regulatory Affairs Coordinator
- Walnut Creek, CA (11 miles from San Leandro, CA)
- 6 days ago
- Walnut Creek, CA (11 miles from San Leandro, CA)
- 6 days 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 (14 miles from San Leandro, CA)
- 6 days ago
- San Francisco, CA (14 miles from San Leandro, CA)
- 6 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 (7 miles from San Leandro, CA)
- 7 days ago
- Alameda, CA (7 miles from San Leandro, CA)
- 7 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)....
Senior Regulatory Affairs Specialist IVD
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 9 days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 9 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
Compliance Analyst (HITRUST framework)
- Menlo Park, CA (17 miles from San Leandro, CA)
- 10 days ago
- Menlo Park, CA (17 miles from San Leandro, CA)
- 10 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 (14 miles from San Leandro, CA)
- 11 days ago
- Fremont, CA (14 miles from San Leandro, CA)
- 11 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...
Senior Regulatory Affairs Specialist - IVD
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 11 days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 11 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
- Pleasanton, CA (17 miles from San Leandro, CA)
- 15 days ago
- Pleasanton, CA (17 miles from San Leandro, CA)
- 15 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 (14 miles from San Leandro, CA)
- 15 days ago
- San Francisco, CA (14 miles from San Leandro, CA)
- 15 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 (17 miles from San Leandro, CA)
- 16 days ago
- Pleasant Hill, CA (17 miles from San Leandro, CA)
- 16 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 (17 miles from San Leandro, CA)
- 16 days ago
- Pleasant Hill, CA (17 miles from San Leandro, CA)
- 16 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 (14 miles from San Leandro, CA)
- 17 days ago
- San Francisco, CA (14 miles from San Leandro, CA)
- 17 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 (17 miles from San Leandro, CA)
- 17 days ago
- Redwood City, CA (17 miles from San Leandro, CA)
- 17 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...
Demographic Data for San Leandro, CA
Moving to San Leandro, CA? Find some basic demographic data about San Leandro, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Leandro, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Leandro, 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
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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