Regulatory Affairs Specialist Jobs in Cupertino, 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 (8 miles from Cupertino, CA)
- 1 day ago
- Santa Clara, CA (8 miles from Cupertino, 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....
Senior Regulatory Affairs Specialist IVD
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 5 days ago
- Sunnyvale, CA (7 miles from Cupertino, 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 (8 miles from Cupertino, CA)
- 5 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 5 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 (20 miles from Cupertino, CA)
- 6 days ago
- Foster City, CA (20 miles from Cupertino, 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 (12 miles from Cupertino, CA)
- 6 days ago
- Menlo Park, CA (12 miles from Cupertino, CA)
- 6 days ago
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
Product Regulatory Compliance Specialist
- Fremont, CA (19 miles from Cupertino, CA)
- 7 days ago
- Fremont, CA (19 miles from Cupertino, CA)
- 7 days ago
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 (7 miles from Cupertino, CA)
- 7 days ago
- Sunnyvale, CA (7 miles from Cupertino, 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 (11 miles from Cupertino, CA)
- 10 days ago
- San Jose, CA (11 miles from Cupertino, 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...
Cybersecurity Risk and Compliance Analyst
- Santa Clara, CA (8 miles from Cupertino, CA)
- 12 days ago
- Santa Clara, CA (8 miles from Cupertino, 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 (11 miles from Cupertino, CA)
- 12 days ago
- San Jose, CA (11 miles from Cupertino, 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 (14 miles from Cupertino, CA)
- 13 days ago
- Redwood City, CA (14 miles from Cupertino, 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 (17 miles from Cupertino, CA)
- 14 days ago
- Milpitas, CA (17 miles from Cupertino, 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...
Regulatory Affairs Specialist - (NMPA/CFDA)
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 21 days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 21 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
- Santa Clara, CA (8 miles from Cupertino, CA)
- 26 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 26 days ago
Regulatory Affairs Associate#25-54412 $43.72 per hour Santa Clara, CA All On-site Job Description Responsible for filing necessary applications and handling all government interactions pertaining...
- Santa Clara, CA (8 miles from Cupertino, CA)
- 26 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 26 days ago
Driving quality system process improvement initiatives Initiatives include but are not limited to: Establishing emerging issues in our quality system, Maintaining the quality system procedures (e.g....
Demographic Data for Cupertino, CA
Moving to Cupertino, CA? Find some basic demographic data about Cupertino, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cupertino, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cupertino, 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
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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