Regulatory Affairs Specialist Jobs in Concord, 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 Concord, CA)
- 1 day ago
- Dublin, CA (17 miles from Concord, 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 PersonPrinciple Regulatory Affairs Specialist - Diabetes Care (on-site)
- Abbott
- Alameda, CA (18 miles from Concord, CA)
- 6 days ago
- Alameda, CA (18 miles from Concord, 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 Concord, CA)
- 6 days ago
- Dublin, CA (17 miles from Concord, 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 (18 miles from Concord, CA)
- 7 days ago
- Alameda, CA (18 miles from Concord, 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 Concord, CA)
- 12 days ago
- Dublin, CA (17 miles from Concord, 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 (24 miles from Concord, CA)
- 16 days ago
- San Francisco, CA (24 miles from Concord, 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 PersonStaff Regulatory Affairs Specialist - Pleasanton, CA
- Calyxo Inc
- Pleasanton, CA (23 miles from Concord, CA)
- 18 days ago
- Pleasanton, CA (23 miles from Concord, 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 (24 miles from Concord, CA)
- 30+ days ago
- San Francisco, CA (24 miles from Concord, 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...
Hybrid- Williams-Sonoma, Inc.
- Richmond, CA (19 miles from Concord, CA)
- 30+ days ago
- Richmond, CA (19 miles from Concord, 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 PersonRegulatory Affairs Specialist 3 - Multiport da Vinci
- Intuitive Surgical
- San Francisco, CA (24 miles from Concord, CA)
- 45+ days ago
- San Francisco, CA (24 miles from Concord, 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 PersonRegulatory Affairs Specialist 3
- Intuitive
- San Francisco, CA (24 miles from Concord, CA)
- 60+ days ago
- San Francisco, CA (24 miles from Concord, CA)
- 60+ 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 PersonCompliance Senior Program Manager
- Adobe Systems Incorporated
- San Francisco, CA (24 miles from Concord, CA)
- 60+ days ago
- San Francisco, CA (24 miles from Concord, CA)
- 60+ days ago
The Opportunity We're seeking a Compliance Senior Program Manager (COI) to lead and evolve Adobe's global conflicts of interest program. This is an exciting opportunity to join Adobe's Legal and...
In PersonCompliance Analyst (Part Time Contractor)
- Unlearn.AI
- San Francisco, CA (24 miles from Concord, CA)
- 60+ days ago
- San Francisco, CA (24 miles from Concord, CA)
- 60+ days ago
Our Mission and Vision Unlearn exists to transform clinical development by making every trial smarter. We harness data, AI, and digital twins to enable faster, more robust studies that bring...
In Person Part TimeGlobal Trade Compliance Analyst
- 1X TECHNOLOGIES
- Hayward, CA (19 miles from Concord, CA)
- 90+ days ago
- Hayward, CA (19 miles from Concord, CA)
- 90+ days ago
Global Trade Compliance Analyst Location: Hayward, CA (On-site) About 1X We build humanoid robots that work alongside people to solve labor shortages and create abundance. Role Summary We are...
In PersonPrincipal Regulatory Affairs Specialist APAC - Diabetes Care (on-site)
- Abbott
- Alameda, CA (18 miles from Concord, CA)
- 90+ days ago
- Alameda, CA (18 miles from Concord, CA)
- 90+ days ago
The Opportunity This Principal Regulatory Affairs Specialist APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division....
In PersonDemographic Data for Concord, CA
Moving to Concord, CA? Find some basic demographic data about Concord, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Concord, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Concord, 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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