Regulatory Affairs Specialist Jobs in San Jose, 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 - Heart Failure
- Pleasanton, CA (20 miles from San Jose, CA)
- 1 day ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 1 day ago
This Regulatory Affairs Specialist II will work out of our Pleasanton, CA location in our Heart Failure Division....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (20 miles from San Jose, CA)
- 3 days ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 3 days ago
Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
Job Title: Associate Regulatory Affairs Specialist, Operations Looking for an entry level candidate looking to gain experience in Regulatory Affairs, NO EXPERIENCE NEEDED....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (20 miles from San Jose, CA)
- 4 days ago
- Pleasanton, CA (20 miles from San Jose, 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...
Sr Regulatory Operations Specialist (Remote) - Shockwave
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing/verification support and Regulatory compliance support....
Remote WorkSr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 4 days ago
J&J Family of Companies Sr Regulatory Affairs Specialist (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything....
Remote WorkTrade Compliance Analyst - INTL - India
- Milpitas, CA (6 miles from San Jose, CA)
- 7 days ago
- Milpitas, CA (6 miles from San Jose, CA)
- 7 days ago
Insight Global Trade Compliance Analyst - INTL - India in Milpitas , California Job Description Trade compliance analyst who will play a key role in ensuring our organization's adherence to trade...
- Pleasanton, CA (20 miles from San Jose, CA)
- 10 days ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 10 days ago
About the company Albertsons Companies is at the forefront of the revolution in retail. With a fixation on raising the bar with innovation and building belonging through our culture, our team is...
Associate Regulatory Affairs Specialist, Operations
- Santa Clara, CA (3 miles from San Jose, CA)
- 16 days ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 16 days ago
Job Title: Associate Regulatory Affairs Specialist, Operations Job Description The Associate Regulatory Affairs Operations Specialist will help secure and retain global regulatory approvals for medical...
Principal Regulatory Affairs Specialist - Heart Failure (on-site)
- Pleasanton, CA (20 miles from San Jose, CA)
- 16 days ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 16 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, NPD
- Sunnyvale, CA (7 miles from San Jose, CA)
- 17 days ago
- Sunnyvale, CA (7 miles from San Jose, CA)
- 17 days ago
Kelly Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location...
Regulatory Affairs Specialist I Department: Quality Employment Type: Full Time Location: US-California-San Jose Compensation: $118,100 - $138,600 / year Description The Sr....
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...
Job Req ID: 26084 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,...
Senior Regulatory Affairs Specialist
- Redwood City, CA (21 miles from San Jose, CA)
- 30+ days ago
- Redwood City, CA (21 miles from San Jose, CA)
- 30+ days ago
Job Summary & Responsibilities The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain...
Demographic Data for San Jose, CA
Moving to San Jose, CA? Find some basic demographic data about San Jose, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Jose, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Jose, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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