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.
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA (14 miles from Fremont, CA)
- 1 day ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 1 day ago
This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division....
Regulatory Affairs Coordinator
- Walnut Creek, CA (21 miles from Fremont, CA)
- 2 days ago
- Walnut Creek, CA (21 miles from Fremont, CA)
- 2 days ago
We are seeking a proactive and strategic Regulatory Affairs Coordinator to join our team and support both our Workers' Compensation and Healthcare lines of business. In this highly visible role,...
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 3 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 3 days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Senior Regulatory Affairs Specialist IVD
- Sunnyvale, CA (12 miles from Fremont, CA)
- 5 days ago
- Sunnyvale, CA (12 miles from Fremont, CA)
- 5 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...
Sr Regulatory Affairs Specialist - Shockwave
- Santa Clara, CA (14 miles from Fremont, CA)
- 6 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 6 days ago
Job title Sr Regulatory Affairs Specialist - Shockwave Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa Clara /...
Remote WorkUS Interchange Compliance Analyst
- Foster City, CA (15 miles from Fremont, CA)
- 6 days ago
- Foster City, CA (15 miles from Fremont, CA)
- 6 days ago
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and...
Compliance Analyst (HITRUST framework)
- Menlo Park, CA (13 miles from Fremont, CA)
- 6 days ago
- Menlo Park, CA (13 miles from Fremont, CA)
- 6 days ago
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
The Group Youll Be A Part Of In the Global Products Group, we are dedicated to excellence in the design and engineering of Lam's etch and deposition products. We drive innovation to ensure our...
Senior Regulatory Affairs Specialist - IVD
- Sunnyvale, CA (12 miles from Fremont, CA)
- 7 days ago
- Sunnyvale, CA (12 miles from Fremont, CA)
- 7 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...
- San Jose, CA (16 miles from Fremont, CA)
- 10 days ago
- San Jose, CA (16 miles from Fremont, CA)
- 10 days ago
Our team is looking for Compliance Analysts with experience working in fast-paced and dynamic cloud services organizations, SaaS/PaaS/IaaS, preferably in a compliance role, or engaged in...
- Pleasanton, CA (9 miles from Fremont, CA)
- 11 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 11 days ago
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
Cybersecurity Risk and Compliance Analyst
- Santa Clara, CA (14 miles from Fremont, CA)
- 12 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 12 days ago
About Marvell Marvells semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier...
Compliance Analyst (Canadian CCCS)
- San Jose, CA (16 miles from Fremont, CA)
- 12 days ago
- San Jose, CA (16 miles from Fremont, CA)
- 12 days ago
Insight Global is looking for a compliance analyst to work remote for an enterprise cloud and security organization. This person will be responsible for ensuring annual cloud and security...
Senior Regulatory Affairs Specialist
- Redwood City, CA (15 miles from Fremont, CA)
- 13 days ago
- Redwood City, CA (15 miles from Fremont, CA)
- 13 days ago
Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory...
Staff Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (13 miles from Fremont, CA)
- 14 days ago
- Milpitas, CA (13 miles from Fremont, CA)
- 14 days ago
Job Overview The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration...
Demographic Data for Fremont, CA
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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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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