Regulatory Affairs Specialist Jobs in Morgan Hill, 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.
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 4 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 4 days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Global Trade Compliance Analyst
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 18 hours ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 18 hours ago
NVIDIA redefined modern computer graphics, high-performance computing and artificial intelligence. We are well positioned as the AI Computing Company, and our GPUs are the brains powering Deep...
- San Jose, CA (18 miles from Morgan Hill, CA)
- 4 days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 4 days ago
System Regulations (QSR); and European quality system standards....
Principal Regulatory Affairs Specialist
- San Jose, CA (18 miles from Morgan Hill, CA)
- 5 days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 5 days ago
Management System Standard ISO 13485 is required Experience with Risk Management Standard ISO 14971 is required Knowledge of EU MDR regulations is required Knowledge of International Medical Device...
- San Jose, CA (18 miles from Morgan Hill, CA)
- 7 days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 7 days ago
More Results Previous Adjunct-Instructor, Sociology Regulatory Affairs Specialist Employer Vital Connect Inc Location San Jose, California, US Salary Competitive Closing date Jul 31, 2025 Apply on website...
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 15 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 15 days ago
Deep knowledge of FDA,ISO 13485, 21 CFR Part 820 regulations and PMA guidance. Advanced degree preferred (MS, PhD, or equivalent experience)....
Customer Audit & Compliance - Analyst
- San Jose, CA (18 miles from Morgan Hill, CA)
- 18 days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 18 days ago
Team Collaboration Work closely with internal audit teams and cross-functional departments to support audit objectives and share insights....
Regulatory Affairs Associate / Labeling Coordinator
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 20 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 20 days ago
Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team....
Export Compliance Analyst / Customer Service
- San Jose, CA (18 miles from Morgan Hill, CA)
- 30+ days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 30+ days ago
Management System and Environmental Management System....
Associate Export & Compliance Analyst
- Campbell, CA (19 miles from Morgan Hill, CA)
- 30+ days ago
- Campbell, CA (19 miles from Morgan Hill, CA)
- 30+ days ago
Associate Export & Compliance Analyst Dallas Metro AreaLegal Division - Legal /Full Time Employee /On-Site Founded in 2015, Shield AI is a venture-backed defense technology company with the...
Sr Regulatory Affairs Specialist - Shockwave Medical
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 30+ days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 30+ days ago
Job title Sr Regulatory Affairs Specialist - Shockwave Medical Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa...
Remote Work- Livermore, CA (23 miles from Morgan Hill, CA)
- 30+ days ago
- Livermore, CA (23 miles from Morgan Hill, CA)
- 30+ days ago
Trade Compliance Analyst FormFactor, Inc Hybrid- Livermore, CA May also consider Beaverton, OR In a world driven by the increased demand of technology, semiconductor manufacturers require a...
Supply Chain Compliance Analyst
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
Certifications like CISA, CISM, or ISO Lead Auditor are a plus. 3+ years of experience in compliance, supply chain operations, process improvement, or internal audit-ideally within hardware-intensive...
Remote Work- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
Participate in internal audits and self-assessments to identify and correct compliance gaps....
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 90+ days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 90+ days ago
This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division....
Demographic Data for Morgan Hill, CA
Moving to Morgan Hill, CA? Find some basic demographic data about Morgan Hill, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morgan Hill, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morgan Hill, 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
- Internal Control
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Written Communication
- Education Experience
- Documentation
- Investigation
- Verbal Communication
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Project Management
- Problem Solving
- Regulations
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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