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.
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
- Santa Clara, CA (8 miles from Cupertino, CA)
- 17 hours ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 17 hours 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...
Technical Software License Compliance Analyst and Auditor
- Palo Alto, CA (10 miles from Cupertino, CA)
- 4 hours ago
- Palo Alto, CA (10 miles from Cupertino, CA)
- 4 hours ago
Please Note:** **1. If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account)** **2. If you already have a Candidate...
A globally leading technology company is looking for a Compliance Analyst to join its Business Conduct and Global Compliance team. This role will focus on global regulatory compliance initiatives,...
Principal Regulatory Affairs Specialist
- San Jose, CA (11 miles from Cupertino, CA)
- 1 day ago
- San Jose, CA (11 miles from Cupertino, CA)
- 1 day ago
Management System Standard ISO 13485 is required Experience with Risk Management Standard ISO 14971 is required Knowledge of EU MDR regulations is required Knowledge of International Medical Device...
- San Jose, CA (11 miles from Cupertino, CA)
- 3 days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 3 days ago
More Results Previous Adjunct-Instructor, Sociology Regulatory Affairs Specialist Employer Vital Connect Inc Location San Jose, California, US Salary Competitive Closing date Jul 31, 2025 Apply on website...
Lead Compliance Analyst, Money
- Menlo Park, CA (12 miles from Cupertino, CA)
- 3 days ago
- Menlo Park, CA (12 miles from Cupertino, CA)
- 3 days ago
Join a leading fintech company that's democratizing finance for all. Robinhood Markets was founded on a simple idea: that our financial markets should be accessible to all. With customers at the...
- Santa Clara, CA (8 miles from Cupertino, CA)
- 11 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 11 days ago
Support quality system improvements and KPI reporting....
- Santa Clara, CA (8 miles from Cupertino, CA)
- 11 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 11 days ago
Deep knowledge of FDA,ISO 13485, 21 CFR Part 820 regulations and PMA guidance. Advanced degree preferred (MS, PhD, or equivalent experience)....
Fiscal Compliance Analyst (Open and Promotional)
- Redwood City, CA (14 miles from Cupertino, CA)
- 13 days ago
- Redwood City, CA (14 miles from Cupertino, CA)
- 13 days ago
Address state, federal, local and internal audits, and public records act requests. Coordinate, track, respond, and compile associated audit reports and responses....
Customer Audit & Compliance - Analyst
- San Jose, CA (11 miles from Cupertino, CA)
- 14 days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 14 days ago
Team Collaboration Work closely with internal audit teams and cross-functional departments to support audit objectives and share insights....
Regulatory Affairs Associate / Labeling Coordinator
- Santa Clara, CA (8 miles from Cupertino, CA)
- 16 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 16 days ago
Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team....
A globally leading technology company is looking for an Export Compliance Analyst to join its high-impact Global Export and Sanctions Compliance (GESC) team. This is a unique opportunity to play a...
Senior Regulatory Affairs Specialist
- Union City, CA (21 miles from Cupertino, CA)
- 17 days ago
- Union City, CA (21 miles from Cupertino, CA)
- 17 days ago
About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA....
Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 24 days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 24 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...
- Palo Alto, CA (10 miles from Cupertino, CA)
- 25 days ago
- Palo Alto, CA (10 miles from Cupertino, CA)
- 25 days ago
A World-Changing Company Palantir builds the worlds leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our...
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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »