Regulatory Affairs Specialist Jobs in San Leandro, 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.
- Pivotal
- Palo Alto, CA (18 miles from San Leandro, CA)
- 1 hour ago
- Palo Alto, CA (18 miles from San Leandro, CA)
- 1 hour ago
Pivotal is the leader in the emerging market of electric Vertical Takeoff and Landing (eVTOL) aircraft. We design, develop, and manufacture light eVTOL aircraft and are renowned for the BlackFly...
In PersonRegulatory Affairs Specialist II/Manager 1
- GRIFOLS, S.A.
- Clayton, CA (20 miles from San Leandro, CA)
- 1 hour ago
- Clayton, CA (20 miles from San Leandro, CA)
- 1 hour ago
Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions....
In PersonGlobal Interchange Compliance Analyst
- Visa
- Foster City, CA (12 miles from San Leandro, CA)
- 5 days ago
- Foster City, CA (12 miles from San Leandro, CA)
- 5 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 (7 miles from San Leandro, CA)
- 6 days ago
- Alameda, CA (7 miles from San Leandro, 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 (13 miles from San Leandro, CA)
- 7 days ago
- Dublin, CA (13 miles from San Leandro, CA)
- 7 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 (7 miles from San Leandro, CA)
- 8 days ago
- Alameda, CA (7 miles from San Leandro, CA)
- 8 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 (13 miles from San Leandro, CA)
- 12 days ago
- Dublin, CA (13 miles from San Leandro, 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...
HybridRegulatory Affairs Specialist (NMPA)
- Intuitive
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 13 days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 13 days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In Person- Systems Integration Solutions, Inc.
- San Francisco, CA (14 miles from San Leandro, CA)
- 16 days ago
- San Francisco, CA (14 miles from San Leandro, 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 (17 miles from San Leandro, CA)
- 17 days ago
- Menlo Park, CA (17 miles from San Leandro, 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 (17 miles from San Leandro, CA)
- 19 days ago
- Pleasanton, CA (17 miles from San Leandro, CA)
- 19 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 (14 miles from San Leandro, CA)
- 30+ days ago
- San Francisco, CA (14 miles from San Leandro, 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...
HybridSenior Supply Chain Compliance Analyst (SOX)
- Core Weave
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 30+ days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 30+ days ago
Partner with Finance SOX, Internal Audit, IT, and supply chain process owners to design and operate effective controls in NetSuite and Coupa (approvals, reconciliations, 3-way match, SoD, access)....
HybridPrincipal Regulatory Affairs Specialist
- Pulmonx
- Redwood City, CA (17 miles from San Leandro, CA)
- 30+ days ago
- Redwood City, CA (17 miles from San Leandro, 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 PersonRegulatory Affairs Specialist 3
- Intuitive
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 30+ days ago
- Sunnyvale, CA (23 miles from San Leandro, CA)
- 30+ 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 San Leandro, CA
Moving to San Leandro, CA? Find some basic demographic data about San Leandro, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Leandro, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Leandro, 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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