Regulatory Affairs Specialist Jobs in Monte Sereno, CA
Regulatory Affairs Associate Director, IVD #4360
- Menlo Park, CA (19 miles from Monte Sereno, CA)
- 18 hours ago
- Menlo Park, CA (19 miles from Monte Sereno, CA)
- 18 hours ago
Direct experience with FDA regulatory submissions required. Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred....
Security and Compliance Analyst Intern
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 1 day ago
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 1 day ago
Security and Compliance Analyst Intern Location Headquarters Employment Type Intern Location Type On-site Department Engineering Compensation $30.00 The pay range for this job level is a general...
- San Jose, CA (9 miles from Monte Sereno, CA)
- 1 day ago
- San Jose, CA (9 miles from Monte Sereno, CA)
- 1 day ago
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- Milpitas, CA (16 miles from Monte Sereno, CA)
- 2 days ago
- Milpitas, CA (16 miles from Monte Sereno, CA)
- 2 days ago
Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices as well as research use only...
Compliance Analyst, AML Investigations
- San Jose, CA (9 miles from Monte Sereno, CA)
- 6 days ago
- San Jose, CA (9 miles from Monte Sereno, CA)
- 6 days ago
Who We Are At OKX, we believe that the future will be reshaped by crypto, and ultimately contribute to every individual's freedom. OKX is a leading crypto exchange, and the developer of OKX...
- Cupertino, CA (7 miles from Monte Sereno, CA)
- 8 days ago
- Cupertino, CA (7 miles from Monte Sereno, CA)
- 8 days ago
ATR ID: ATR223641 Job Title: Export Compliance Analyst Job Level: Analyst Duration: 12 months Location: Cupertino CA 95014 Education: Bachelors degree in international business, international...
Regulatory Affairs Specialist 3
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 8 days ago
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 8 days ago
Author regulatory submissions for US FDA 510(k) premarket notifications, internal Letters to File and Health Canada registration, and lead the review process through clearance/approval, where applicable...
- San Jose, CA (9 miles from Monte Sereno, CA)
- 12 days ago
- San Jose, CA (9 miles from Monte Sereno, CA)
- 12 days ago
Our team is looking for Compliance Analysts with experience working in fast-paced and dynamic cloud services organizations, SaaS/PaaS/IaaS, preferably in a compliance role, or engaged in...
- San Jose, CA (9 miles from Monte Sereno, CA)
- 13 days ago
- San Jose, CA (9 miles from Monte Sereno, CA)
- 13 days ago
Respond thoughtfully and quickly to inquiries, critical issues, and risk identification received from compliance teams, internal audit, deal desks, employees, and management....
Regulatory Affairs Specialist - Ion
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 15 days ago
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 15 days ago
Roles and Responsibilities: Prepare and submit sections of or complete 510(k)s (FDA) to obtain regulatory clearances for new products, new indications, and significant product changes in a timely manner...
- Santa Cruz, CA (14 miles from Monte Sereno, CA)
- 21 days ago
- Santa Cruz, CA (14 miles from Monte Sereno, CA)
- 21 days ago
Research Compliance Analyst University of California Santa Cruz in Santa Cruz, CA Apply Now Type: Full-Time Salary: Salary: $100,000 - $106,000/year Posted: 09/23/2025 Category: Assessment,...
Remote WorkRegulatory Compliance Analyst (20662934)
- Menlo Park, CA (19 miles from Monte Sereno, CA)
- 27 days ago
- Menlo Park, CA (19 miles from Monte Sereno, CA)
- 27 days ago
San Francisco/Peninsula Job Type Full-Time Close Date 10/1/2025 at 8am Salary $133,873.00-$162,723.00 Annually Additional Questionnaires Pre-qualification and Supplemental About Menlo Park Menlo...
Sr Regulatory Affairs Specialist
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 30+ days ago
- Sunnyvale, CA (11 miles from Monte Sereno, CA)
- 30+ days ago
submissions of various types, including US FDA 510(k) premarket notifications, and internal Letters to File, as applicable....
Senior Regulatory Affairs Specialist
- Santa Clara, CA (8 miles from Monte Sereno, CA)
- 30+ days ago
- Santa Clara, CA (8 miles from Monte Sereno, CA)
- 30+ days ago
General Responsibilities: Prepare regulatory submissions to support product commercialization (e.g. 510(k), CE Mark Technical File, International)....
- Milpitas, CA (16 miles from Monte Sereno, CA)
- 30+ days ago
- Milpitas, CA (16 miles from Monte Sereno, CA)
- 30+ days ago
The corporate team provides a broad range of services, such as financial planning, corporate accounting, tax, industry analysis and benchmarking, internal audits, SEC reporting and merger and acquisition...
Demographic Data for Monte Sereno, CA
Moving to Monte Sereno, CA? Find some basic demographic data about Monte Sereno, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Monte Sereno, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Monte Sereno, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- ICH Guidelines
- 21 CFR 820
- Institutional Review Board
- ISO 13485
- Quality Systems
- Quality Management Systems
- Validation
- Medical Device Sales
- Microsoft Visio
- FDA Regulations
- Corrective Actions & Preventive Actions
- Root Cause Analysis
- Continuous Improvement
- Standard Operating Procedures
- Product Development
- Strategy Development
- Reimbursement
- Risk Management
- Engineering
- Military Background
- Analytical Skills
- Written Communication
- Implementation
- Auditing
- Process Improvement
- Microsoft Outlook
- Documentation
- Verbal Communication
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Regulations
- Filing
- Education Experience
- Project Management
- Time Management
- Research Skills
- Microsoft Office
- Computer Skills
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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