Regulatory Affairs Specialist Jobs in Palo Alto, 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.
Senior Regulatory Affairs Specialist, Labeling
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 14 hours ago
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 14 hours ago
Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485)....
Senior Regulatory Affairs Specialist, Labeling
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 20 hours ago
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 20 hours ago
Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485)....
Senior Regulatory Affairs Specialist, NPD
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 20 hours ago
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 20 hours ago
Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, New Product Development Position Type: one-year month contract Pay rate: $47-50/ hour....
- Fremont, CA (12 miles from Palo Alto, CA)
- 1 day ago
- Fremont, CA (12 miles from Palo Alto, CA)
- 1 day 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...
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- Fremont, CA (12 miles from Palo Alto, CA)
- 1 day ago
- Fremont, CA (12 miles from Palo Alto, CA)
- 1 day 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...
Senior Privacy Compliance Analyst
- Mountain View, CA (5 miles from Palo Alto, CA)
- 3 days ago
- Mountain View, CA (5 miles from Palo Alto, CA)
- 3 days ago
About GetInsured; What started as the "Expedia" of health insurance, has grown to a market leading company that is transforming government IT infrastructures with our proven SaaS and AI...
Security and Compliance Analyst
- Mountain View, CA (5 miles from Palo Alto, CA)
- 4 days ago
- Mountain View, CA (5 miles from Palo Alto, CA)
- 4 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...
Principal Risk & Compliance Analyst
- Oakland, CA (23 miles from Palo Alto, CA)
- 4 days ago
- Oakland, CA (23 miles from Palo Alto, CA)
- 4 days ago
Requisition ID # 165320 Job Category: Compliance / Risk / Quality Assurance Job Level: Manager/Principal Business Unit: Gen Counsel, Ethics, Risk & Compliance Work Type: Hybrid Job Location:...
Regulatory Affairs Specialist, NPD
- San Jose, CA (15 miles from Palo Alto, CA)
- 5 days ago
- San Jose, CA (15 miles from Palo Alto, 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...
- Milpitas, CA (18 miles from Palo Alto, CA)
- 13 days ago
- Milpitas, CA (18 miles from Palo Alto, CA)
- 13 days ago
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 (12 miles from Palo Alto, CA)
- 15 days ago
- Santa Clara, CA (12 miles from Palo Alto, CA)
- 15 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....
Principal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (23 miles from Palo Alto, CA)
- 17 days ago
- Alameda, CA (23 miles from Palo Alto, CA)
- 17 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 IVD
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 20 days ago
- Sunnyvale, CA (8 miles from Palo Alto, 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...
Product Regulatory Compliance Specialist
- Fremont, CA (12 miles from Palo Alto, CA)
- 21 days ago
- Fremont, CA (12 miles from Palo Alto, CA)
- 21 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 (8 miles from Palo Alto, CA)
- 21 days ago
- Sunnyvale, CA (8 miles from Palo Alto, CA)
- 21 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...
Demographic Data for Palo Alto, CA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Palo Alto, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Palo Alto, 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
- Resolution
- Microsoft SharePoint
- Product Development
- Risk Management
- Affirmative Action
- 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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