Regulatory Affairs Specialist Jobs in Santa Cruz, 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 - Onsite
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 14 hours ago
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 14 hours ago
Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop labeling strategies....
Senior Regulatory Affairs Specialist, Labeling
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485)....
Senior Regulatory Affairs Specialist, Labeling
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485)....
Senior Regulatory Affairs Specialist, NPD
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 1 day ago
Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, New Product Development Position Type: one-year month contract Pay rate: $47-50/ hour....
/19300/f07371e6-c1d3-4ee2-beed-850b296ffa0e.png&z=8&s=QCL&ih_t=5%2F15%2F2025+7%3A36%3A31+AM&utm_medium=internal%20referrer&utm_campaign=internal-ihire-resume-review&utm_content=ihire&utm_term=sf_serp_searchresults_position_5&dt=Desktop)
Senior Privacy Compliance Analyst
- Mountain View, CA (24 miles from Santa Cruz, CA)
- 3 days ago
- Mountain View, CA (24 miles from Santa Cruz, CA)
- 3 days ago
About GetInsured; What started as the "Expedia" of health insurance, has grown to a market leading company that is transforming government IT infrastructures with our proven SaaS and AI...
Security and Compliance Analyst
- Mountain View, CA (24 miles from Santa Cruz, CA)
- 4 days ago
- Mountain View, CA (24 miles from Santa Cruz, CA)
- 4 days ago
About Haus Haus is a first of its kind decision science platform for the new digital privacy paradigm where data sharing and PII is restricted. Haus uses frontier causal inference based...
Regulatory Affairs Specialist, NPD
- San Jose, CA (24 miles from Santa Cruz, CA)
- 6 days ago
- San Jose, CA (24 miles from Santa Cruz, CA)
- 6 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...
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 16 days ago
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 16 days 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 (23 miles from Santa Cruz, CA)
- 20 days ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 20 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...
Senior Regulatory Affairs Specialist - IVD
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 22 days ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 22 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 (24 miles from Santa Cruz, CA)
- 25 days ago
- San Jose, CA (24 miles from Santa Cruz, CA)
- 25 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 (22 miles from Santa Cruz, CA)
- 27 days ago
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 27 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...
Regulatory Affairs Specialist - (NMPA/CFDA)
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 30+ days ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 30+ 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 (22 miles from Santa Cruz, CA)
- 30+ days ago
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 30+ 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 (22 miles from Santa Cruz, CA)
- 30+ days ago
- Santa Clara, CA (22 miles from Santa Cruz, CA)
- 30+ 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 Santa Cruz, CA
Moving to Santa Cruz, CA? Find some basic demographic data about Santa Cruz, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Santa Cruz, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Santa Cruz, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- 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 »