Regulatory Affairs Specialist Jobs in Cupertino, 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.
Global Interchange Compliance Analyst
- Visa
- Foster City, CA (20 miles from Cupertino, CA)
- 5 days ago
- Foster City, CA (20 miles from Cupertino, CA)
- 5 days ago
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and...
In PersonRegulatory Affairs Specialist (NMPA)
- Intuitive
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 13 days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 13 days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In PersonCompliance Analyst Cupertino, CA-95014 6+ months Hybrid (Tues, Wed, Thurs in office/week) Duties This position will be part of the Business Conduct and Compliance team. Specifically, the position...
In PersonA globally leading consumer device company headquartered in Cupertino, CA is looking for a Compliance Analyst to join their team. Job Responsibilities: Support global regulatory compliance...
HybridSr. FTZ Compliance Analyst (29037)
- Super Micro Computer, Inc.
- San Jose, CA (11 miles from Cupertino, CA)
- 15 days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 15 days ago
Job Req ID: 29037 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data,...
In PersonLocation: Cupertino, CA Hybrid Introduction This position will be part of the Business Conduct and Compliance team, focusing on global regulatory compliance initiatives, primarily related to third...
In Person- INSPYR Solutions
- Menlo Park, CA (12 miles from Cupertino, CA)
- 17 days ago
- Menlo Park, CA (12 miles from Cupertino, CA)
- 17 days ago
Title: Compliance Analyst Location: Remote US - Must be available in PST hours Duration: 12+ months Compensation: $40-70/hr Work Requirements: US Citizen, GC Holders or Authorized to Work in the...
RemoteGRC Compliance Analyst (GRC = Governance, Risk, and Compliance) About this Featured Opportunity: We're looking for a hands-on GRC Automation Consultant to automate compliance workflows, close data...
In PersonSenior Supply Chain Compliance Analyst (SOX)
- Core Weave
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 30+ days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 30+ days ago
Partner with Finance SOX, Internal Audit, IT, and supply chain process owners to design and operate effective controls in NetSuite and Coupa (approvals, reconciliations, 3-way match, SoD, access)....
HybridPrincipal Regulatory Affairs Specialist
- Pulmonx
- Redwood City, CA (14 miles from Cupertino, CA)
- 30+ days ago
- Redwood City, CA (14 miles from Cupertino, CA)
- 30+ days ago
Position Overview The Principal Regulatory Affairs Specialist drives the full spectrum of regulatory activities, from initial market authorization through post-market compliance, for Pulmonx's US and...
In Person- 101 Bloom Energy
- San Jose, CA (11 miles from Cupertino, CA)
- 30+ days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 30+ days ago
At Bloom Energy, our vision for a world powered by clean, reliable, and affordable energy is more than just a dreamwe're making it reality. For over two decades, we've been at the forefront of the...
In PersonRegulatory Affairs Specialist 3
- Intuitive
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 30+ days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 30+ days ago
The Regulatory Affairs Specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts...
In PersonTitle IX & Title VI Case Management and Compliance Analyst
- Stanford University
- Palo Alto, CA (10 miles from Cupertino, CA)
- 30+ days ago
- Palo Alto, CA (10 miles from Cupertino, CA)
- 30+ days ago
Title IX & Title VI Case Management and Compliance Analyst Institutional Equity & Access, Stanford, California, United States NewAdministration1 day ago Post Date108888 Requisition # The Sexual...
In Person Full TimeSenior Trade Compliance Analyst
- ZP Group
- San Jose, CA (11 miles from Cupertino, CA)
- 45+ days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 45+ days ago
Piper Companies is seeking a Senior Trade Compliance Analyst to join a global organization operating within a highly regulated multinational environment onsite in San Jose, CA Monday - Friday. The...
In PersonSenior Regulatory Affairs Specialist
- Hyperfine Inc
- Palo Alto, CA (10 miles from Cupertino, CA)
- 45+ days ago
- Palo Alto, CA (10 miles from Cupertino, CA)
- 45+ days ago
Learn More About The Role Job Title: Senior Regulatory Affairs Specialist Location: Palo Alto, CA or Guilford, CT (Hybrid, 3 days/week) The Senior Regulatory Affairs Specialist advises regulatory strategy...
HybridDemographic Data for Cupertino, CA
Moving to Cupertino, CA? Find some basic demographic data about Cupertino, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cupertino, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cupertino, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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