Regulatory Affairs Specialist Jobs in Pleasanton, 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.
- Patelco Credit Union
- Dublin, CA (5 miles from Pleasanton, CA)
- 1 day ago
- Dublin, CA (5 miles from Pleasanton, CA)
- 1 day ago
About Patelco Credit Union Patelco Credit Union is a not-for-profit credit union with a purpose to build financial health and wellbeing for our members. Since 1936, Patelco has grown from $500 in...
In PersonGlobal Interchange Compliance Analyst
- Visa
- Foster City, CA (23 miles from Pleasanton, CA)
- 4 days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 4 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 PersonSenior Regulatory Affairs Specialist
- LHH
- Dublin, CA (5 miles from Pleasanton, CA)
- 6 days ago
- Dublin, CA (5 miles from Pleasanton, CA)
- 6 days ago
Title: Senior Regulatory Affairs Specialist (Medical Device) Location: East Bay, CA Send Resumes to: ......
In PersonComplaint Management & Consumer Protection Compliance Analyst
- Patelco Credit Union
- Dublin, CA (5 miles from Pleasanton, CA)
- 12 days ago
- Dublin, CA (5 miles from Pleasanton, CA)
- 12 days ago
About Patelco Credit Union Patelco Credit Union is a not-for-profit credit union with a purpose to build financial health and wellbeing for our members. Since 1936, Patelco has grown from $500 in...
HybridRegulatory Affairs Specialist (NMPA)
- Intuitive
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 13 days ago
- Sunnyvale, CA (19 miles from Pleasanton, 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 PersonSr. FTZ Compliance Analyst (29037)
- Super Micro Computer, Inc.
- San Jose, CA (20 miles from Pleasanton, CA)
- 14 days ago
- San Jose, CA (20 miles from Pleasanton, CA)
- 14 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 Person- INSPYR Solutions
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 17 days ago
- Menlo Park, CA (22 miles from Pleasanton, 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...
RemoteStaff Regulatory Affairs Specialist - Pleasanton, CA
- Calyxo Inc
- Pleasanton, CA
- 18 days ago
- Pleasanton, CA
- 18 days ago
Summary: We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization....
In PersonSenior Supply Chain Compliance Analyst (SOX)
- Core Weave
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 30+ days ago
- Sunnyvale, CA (19 miles from Pleasanton, 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 (24 miles from Pleasanton, CA)
- 30+ days ago
- Redwood City, CA (24 miles from Pleasanton, 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 (20 miles from Pleasanton, CA)
- 30+ days ago
- San Jose, CA (20 miles from Pleasanton, 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 (19 miles from Pleasanton, CA)
- 30+ days ago
- Sunnyvale, CA (19 miles from Pleasanton, 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 (21 miles from Pleasanton, CA)
- 30+ days ago
- Palo Alto, CA (21 miles from Pleasanton, 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 (20 miles from Pleasanton, CA)
- 45+ days ago
- San Jose, CA (20 miles from Pleasanton, 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 (21 miles from Pleasanton, CA)
- 45+ days ago
- Palo Alto, CA (21 miles from Pleasanton, 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 Pleasanton, CA
Moving to Pleasanton, CA? Find some basic demographic data about Pleasanton, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pleasanton, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pleasanton, 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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