Regulatory Affairs Specialist Jobs in Milpitas, 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.
- Fremont, CA (13 miles from Milpitas, CA)
- 7 hours ago
- Fremont, CA (13 miles from Milpitas, CA)
- 7 hours ago
Trade Compliance Analyst Fremont, CA or Remote Temporary $60-64/hr Kelly is seeking a Trade Compliance Analyst to work with our client, a leader in the biotech industry, on a temporary basis...
- Fremont, CA (13 miles from Milpitas, CA)
- 14 hours ago
- Fremont, CA (13 miles from Milpitas, CA)
- 14 hours ago
Trade Compliance Analyst Fremont, CA or Remote Temporary $60-64/hr Kelly is seeking a Trade Compliance Analyst to work with our client, a leader in the biotech industry, on a temporary basis...
IT SOX Compliance Analyst - Pleasanton CA - Hybrid
- Pleasanton, CA (15 miles from Milpitas, CA)
- 1 day ago
- Pleasanton, CA (15 miles from Milpitas, CA)
- 1 day ago
IT SOX Compliance Analyst - Pleasanton CA - Hybrid IT SOX Compliance Analyst Contract Hybrid Pleasanton CA ONSITE - Hybrid Responsibilities: Enforce the audit calendar in performing SOX compliance...
Security and Compliance Analyst
- Mountain View, CA (12 miles from Milpitas, CA)
- 3 days ago
- Mountain View, CA (12 miles from Milpitas, CA)
- 3 days ago
About Haus Haus is a first of its kind decision science platform for the new digital privacy paradigm where data sharing and PII is restricted. Haus uses frontier causal inference based...
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Regulatory Affairs Specialist, NPD
- San Jose, CA (6 miles from Milpitas, CA)
- 4 days ago
- San Jose, CA (6 miles from Milpitas, CA)
- 4 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...
Regulatory Operations Specialist
- Newark, CA (14 miles from Milpitas, CA)
- 5 days ago
- Newark, CA (14 miles from Milpitas, CA)
- 5 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Trade compliance analyst who will play a key role in ensuring our organization's adherence to trade regulations and standards. The candidate will possess strong analytics skills, a background in...
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA (8 miles from Milpitas, CA)
- 14 days ago
- Santa Clara, CA (8 miles from Milpitas, CA)
- 14 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....
Senior Regulatory Affairs Specialist IVD
- Sunnyvale, CA (11 miles from Milpitas, CA)
- 18 days ago
- Sunnyvale, CA (11 miles from Milpitas, CA)
- 18 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
Product Regulatory Compliance Specialist
- Fremont, CA (13 miles from Milpitas, CA)
- 20 days ago
- Fremont, CA (13 miles from Milpitas, CA)
- 20 days ago
You will work directly with our engineering community, supply-chain management, and fellow product safety and environmental engineers to ensure evolving regulations are monitored, assessments of...
Senior Regulatory Affairs Specialist - IVD
- Sunnyvale, CA (11 miles from Milpitas, CA)
- 20 days ago
- Sunnyvale, CA (11 miles from Milpitas, CA)
- 20 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
- San Jose, CA (6 miles from Milpitas, CA)
- 23 days ago
- San Jose, CA (6 miles from Milpitas, CA)
- 23 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...
- Pleasanton, CA (15 miles from Milpitas, CA)
- 24 days ago
- Pleasanton, CA (15 miles from Milpitas, CA)
- 24 days ago
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
Cybersecurity Risk and Compliance Analyst
- Santa Clara, CA (8 miles from Milpitas, CA)
- 25 days ago
- Santa Clara, CA (8 miles from Milpitas, CA)
- 25 days ago
About Marvell Marvells semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier...
Job Overview The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration...
Demographic Data for Milpitas, CA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Milpitas, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Milpitas, 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
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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