Regulatory Affairs Specialist Jobs in Oakland, 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.
- Patelco Credit Union
- Dublin, CA (17 miles from Oakland, CA)
- 1 day ago
- Dublin, CA (17 miles from Oakland, CA)
- 1 day ago
About Patelco Credit Union Patelco Credit Union is a not-for-profit credit union with a purpose to build financial health and wellbeing for our members. Since 1936, Patelco has grown from $500 in...
In PersonGlobal Interchange Compliance Analyst
- Visa
- Foster City, CA (15 miles from Oakland, CA)
- 4 days ago
- Foster City, CA (15 miles from Oakland, CA)
- 4 days ago
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and...
In PersonPrinciple Regulatory Affairs Specialist - Diabetes Care (on-site)
- Abbott
- Alameda, CA (3 miles from Oakland, CA)
- 6 days ago
- Alameda, CA (3 miles from Oakland, CA)
- 6 days ago
Experience with either 510(k) applications, PMA supplements, US Device regulations, or with EU and other international medical device regulations and submissions....
In PersonSenior Regulatory Affairs Specialist
- LHH
- Dublin, CA (17 miles from Oakland, CA)
- 6 days ago
- Dublin, CA (17 miles from Oakland, CA)
- 6 days ago
Title: Senior Regulatory Affairs Specialist (Medical Device) Location: East Bay, CA Send Resumes to: ......
In PersonPrincipal Regulatory Affairs Specialist Diabetes Care (on-site)
- Abbott Laboratories
- Alameda, CA (3 miles from Oakland, CA)
- 7 days ago
- Alameda, CA (3 miles from Oakland, CA)
- 7 days ago
Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines....
In PersonComplaint Management & Consumer Protection Compliance Analyst
- Patelco Credit Union
- Dublin, CA (17 miles from Oakland, CA)
- 12 days ago
- Dublin, CA (17 miles from Oakland, CA)
- 12 days ago
About Patelco Credit Union Patelco Credit Union is a not-for-profit credit union with a purpose to build financial health and wellbeing for our members. Since 1936, Patelco has grown from $500 in...
Hybrid- Systems Integration Solutions, Inc.
- San Francisco, CA (11 miles from Oakland, CA)
- 16 days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 16 days ago
GRC Compliance Analyst (Automation & Data Governance) Type: W-2 Contract Location: San Francisco, CA (Hybrid Onsite) Duration: 6 months++ Pay Rate: $66.94/hr We are seeking an experienced GRC...
In Person- INSPYR Solutions
- Menlo Park, CA (22 miles from Oakland, CA)
- 17 days ago
- Menlo Park, CA (22 miles from Oakland, CA)
- 17 days ago
Title: Compliance Analyst Location: Remote US - Must be available in PST hours Duration: 12+ months Compensation: $40-70/hr Work Requirements: US Citizen, GC Holders or Authorized to Work in the...
RemoteStaff Regulatory Affairs Specialist - Pleasanton, CA
- Calyxo Inc
- Pleasanton, CA (21 miles from Oakland, CA)
- 18 days ago
- Pleasanton, CA (21 miles from Oakland, CA)
- 18 days ago
Summary: We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization....
In PersonSecurity Risk and Compliance Analyst
- Asana
- San Francisco, CA (11 miles from Oakland, CA)
- 30+ days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 30+ days ago
Role Overview As a Security Risk and Compliance Analyst you will play a hands-on role in maturing and operating Asana's compliance and certification programme-specifically across controls...
HybridPrincipal Regulatory Affairs Specialist
- Pulmonx
- Redwood City, CA (21 miles from Oakland, CA)
- 30+ days ago
- Redwood City, CA (21 miles from Oakland, CA)
- 30+ days ago
Position Overview The Principal Regulatory Affairs Specialist drives the full spectrum of regulatory activities, from initial market authorization through post-market compliance, for Pulmonx's US and...
In PersonTitle IX & Title VI Case Management and Compliance Analyst
- Stanford University
- Palo Alto, CA (23 miles from Oakland, CA)
- 30+ days ago
- Palo Alto, CA (23 miles from Oakland, CA)
- 30+ days ago
Title IX & Title VI Case Management and Compliance Analyst Institutional Equity & Access, Stanford, California, United States NewAdministration1 day ago Post Date108888 Requisition # The Sexual...
In Person Full Time- Williams-Sonoma, Inc.
- Richmond, CA (15 miles from Oakland, CA)
- 30+ days ago
- Richmond, CA (15 miles from Oakland, CA)
- 30+ days ago
About Williams Sonoma DC - Memphis & Olive Branch Since it was founded in 1956, Williams - Sonoma has grown from Chuck Williams' single store in Sonoma, CA into one of the largest retailers in the...
In PersonSenior Regulatory Affairs Specialist
- Hyperfine Inc
- Palo Alto, CA (23 miles from Oakland, CA)
- 45+ days ago
- Palo Alto, CA (23 miles from Oakland, CA)
- 45+ days ago
Learn More About The Role Job Title: Senior Regulatory Affairs Specialist Location: Palo Alto, CA or Guilford, CT (Hybrid, 3 days/week) The Senior Regulatory Affairs Specialist advises regulatory strategy...
HybridRegulatory Affairs Specialist 3 - Multiport da Vinci
- Intuitive Surgical
- San Francisco, CA (11 miles from Oakland, CA)
- 45+ days ago
- San Francisco, CA (11 miles from Oakland, CA)
- 45+ days ago
The Regulatory Affairs Specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts...
In PersonDemographic Data for Oakland, CA
Moving to Oakland, CA? Find some basic demographic data about Oakland, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Oakland, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Oakland, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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