Regulatory Affairs Specialist Jobs in Fremont, 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 (11 miles from Fremont, CA)
- 1 day ago
- Dublin, CA (11 miles from Fremont, 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 Fremont, CA)
- 4 days ago
- Foster City, CA (15 miles from Fremont, 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 (21 miles from Fremont, CA)
- 6 days ago
- Alameda, CA (21 miles from Fremont, 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 (11 miles from Fremont, CA)
- 6 days ago
- Dublin, CA (11 miles from Fremont, 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 (21 miles from Fremont, CA)
- 7 days ago
- Alameda, CA (21 miles from Fremont, 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 (11 miles from Fremont, CA)
- 12 days ago
- Dublin, CA (11 miles from Fremont, 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 (12 miles from Fremont, CA)
- 12 days ago
- Sunnyvale, CA (12 miles from Fremont, CA)
- 12 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- TalentBurst
- Cupertino, CA (19 miles from Fremont, CA)
- 13 days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 13 days ago
Compliance Analyst Cupertino, CA-95014 6+ months Hybrid (Tues, Wed, Thurs in office/week) Duties This position will be part of the Business Conduct and Compliance team. Specifically, the position...
In Person- OSI Engineering, Inc.
- Cupertino, CA (19 miles from Fremont, CA)
- 13 days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 13 days ago
A globally leading consumer device company headquartered in Cupertino, CA is looking for a Compliance Analyst to join their team. Job Responsibilities: Support global regulatory compliance...
HybridSr. FTZ Compliance Analyst (29037)
- Super Micro Computer, Inc.
- San Jose, CA (16 miles from Fremont, CA)
- 14 days ago
- San Jose, CA (16 miles from Fremont, CA)
- 14 days ago
Job Req ID: 29037 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data,...
In Person- Cupertino, CA (19 miles from Fremont, CA)
- 15 days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 15 days ago
Location: Cupertino, CA Hybrid Introduction This position will be part of the Business Conduct and Compliance team, focusing on global regulatory compliance initiatives, primarily related to third...
In Person- INSPYR Solutions
- Menlo Park, CA (13 miles from Fremont, CA)
- 17 days ago
- Menlo Park, CA (13 miles from Fremont, 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...
Remote- INSPYR Solutions
- Cupertino, CA (19 miles from Fremont, CA)
- 18 days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 18 days ago
GRC Compliance Analyst (GRC = Governance, Risk, and Compliance) About this Featured Opportunity: We're looking for a hands-on GRC Automation Consultant to automate compliance workflows, close data...
In PersonStaff Regulatory Affairs Specialist - Pleasanton, CA
- Calyxo Inc
- Pleasanton, CA (9 miles from Fremont, CA)
- 18 days ago
- Pleasanton, CA (9 miles from Fremont, 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 PersonSenior Supply Chain Compliance Analyst (SOX)
- Core Weave
- Sunnyvale, CA (12 miles from Fremont, CA)
- 30+ days ago
- Sunnyvale, CA (12 miles from Fremont, 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)....
HybridDemographic Data for Fremont, CA
Moving to Fremont, CA? Find some basic demographic data about Fremont, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fremont, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fremont, 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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