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 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...
Regulatory Affairs Specialist - Shockwave Medical
- Santa Clara, CA (3 miles from San Jose, CA)
- 8 hours ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 8 hours ago
Job title Regulatory Affairs Specialist - Shockwave Medical Function Regulatory Affairs Group Sub function Regulatory Affairs Category Analyst, Regulatory Affairs (P4 - E24) Location Santa Clara / United...
Remote WorkOur 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...
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- Santa Clara, CA (3 miles from San Jose, CA)
- 1 day ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 1 day ago
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave- Function Regulatory Affairs Group- Sub function Regulatory Affairs- Category Experienced Analyst, Regulatory Affairs (P5)- Location...
Remote WorkRegulatory Affairs Specialist 2
- Sunnyvale, CA (7 miles from San Jose, CA)
- 2 days ago
- Sunnyvale, CA (7 miles from San Jose, CA)
- 2 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Sr Regulatory Affairs Specialist - 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
Job title Sr Regulatory Affairs Specialist - Shockwave Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa Clara /...
Remote WorkRegulatory Affairs Specialist Mandarin Speaking
- Sunnyvale, CA (7 miles from San Jose, CA)
- 5 days ago
- Sunnyvale, CA (7 miles from San Jose, CA)
- 5 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Insight Global is looking for a Compliance Analyst to work remote for an enterprise cloud and security organization. This person will be responsible for ensuring annual cloud and security...
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Milpitas, CA (6 miles from San Jose, CA)
- 9 days ago
- Milpitas, CA (6 miles from San Jose, CA)
- 9 days ago
The Opportunity As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including...
Regulatory Operations Specialist
- Newark, CA (15 miles from San Jose, CA)
- 9 days ago
- Newark, CA (15 miles from San Jose, CA)
- 9 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Regulatory Affairs Specialist - Pleasanton, CA
- Pleasanton, CA (20 miles from San Jose, CA)
- 9 days ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 9 days ago
devices, including the Quality System Regulation (QSR), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs)....
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market....
Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist
- Sunnyvale, CA (7 miles from San Jose, CA)
- 13 days ago
- Sunnyvale, CA (7 miles from San Jose, CA)
- 13 days ago
Salary Range: Regulatory Affairs Specialist: $90,600 - $116,400* Senior Regulatory Affairs Specialist: $117,700 - $151,300* Base pay is one part of your total compensation....
Senior Regulatory Affairs Specialist, IVDR
- Sunnyvale, CA (7 miles from San Jose, CA)
- 13 days ago
- Sunnyvale, CA (7 miles from San Jose, CA)
- 13 days ago
Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, IVDR Position Type: one-year month contract Pay rate: $47-50/ hour....
- Santa Clara, CA (3 miles from San Jose, CA)
- 15 days ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 15 days ago
Driving quality system process improvement initiatives Initiatives include but are not limited to : Establishing emerging issues in our quality system, Maintaining the quality system procedures (e.g...
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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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