Regulatory Affairs Specialist Jobs in Soquel, 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 (22 miles from Soquel, CA)
- 60+ days ago
- Santa Clara, CA (22 miles from Soquel, CA)
- 60+ 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....
Principal Regulatory Affairs Specialist
- San Jose, CA (21 miles from Soquel, CA)
- 2 days ago
- San Jose, CA (21 miles from Soquel, CA)
- 2 days 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...
Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
- Sunnyvale, CA (24 miles from Soquel, CA)
- 3 days ago
- Sunnyvale, CA (24 miles from Soquel, CA)
- 3 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...
Export Compliance Analyst / Customer Service
- San Jose, CA (21 miles from Soquel, CA)
- 10 days ago
- San Jose, CA (21 miles from Soquel, CA)
- 10 days ago
Management System and Environmental Management System....
Associate Export & Compliance Analyst
- Campbell, CA (17 miles from Soquel, CA)
- 12 days ago
- Campbell, CA (17 miles from Soquel, CA)
- 12 days ago
Associate Export & Compliance Analyst Dallas Metro AreaLegal Division - Legal /Full Time Employee /On-Site Founded in 2015, Shield AI is a venture-backed defense technology company with the...
Sr Regulatory Affairs Specialist - Shockwave Medical
- Santa Clara, CA (22 miles from Soquel, CA)
- 12 days ago
- Santa Clara, CA (22 miles from Soquel, CA)
- 12 days ago
Job title Sr Regulatory Affairs Specialist - Shockwave Medical Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa...
Remote WorkRegulatory Affairs Specialist, NPD
- Sunnyvale, CA (24 miles from Soquel, CA)
- 13 days ago
- Sunnyvale, CA (24 miles from Soquel, CA)
- 13 days ago
Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain...
Supply Chain Compliance Analyst
- San Jose, CA (21 miles from Soquel, CA)
- 20 days ago
- San Jose, CA (21 miles from Soquel, CA)
- 20 days ago
Certifications like CISA, CISM, or ISO Lead Auditor are a plus. 3+ years of experience in compliance, supply chain operations, process improvement, or internal audit-ideally within hardware-intensive...
Remote WorkPrincipal International Regulatory Affairs Associate
- Cupertino, CA (19 miles from Soquel, CA)
- 21 days ago
- Cupertino, CA (19 miles from Soquel, CA)
- 21 days ago
Job Summary Summary Posted: Jun 20, 2025 Role Number: 200610139 Our ever-evolving suite of Health and Wellness products for iPhone and Watch is helping our users live more active, healthier lives....
- San Jose, CA (21 miles from Soquel, CA)
- 22 days ago
- San Jose, CA (21 miles from Soquel, CA)
- 22 days ago
Participate in internal audits and self-assessments to identify and correct compliance gaps....
Regulatory Affairs Specialist II
- Santa Cruz, CA (12 miles from Soquel, CA)
- 23 days ago
- Santa Cruz, CA (12 miles from Soquel, CA)
- 23 days ago
Regulatory Affairs Specialist II Central California Alliance for Health paid time off, paid holidays, retirement plan United States, California, Santa Cruz Jun 14, 2025 Regulatory Affairs Specialist...
- San Jose, CA (21 miles from Soquel, CA)
- 27 days ago
- San Jose, CA (21 miles from Soquel, CA)
- 27 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...
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- Santa Clara, CA (22 miles from Soquel, CA)
- 27 days ago
- Santa Clara, CA (22 miles from Soquel, CA)
- 27 days ago
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave- Function Regulatory Affairs Group- Sub function Regulatory Affairs- Category Experienced Analyst, Regulatory Affairs (P5)- Location...
Remote WorkRegulatory Affairs Specialist 2
- Sunnyvale, CA (24 miles from Soquel, CA)
- 28 days ago
- Sunnyvale, CA (24 miles from Soquel, CA)
- 28 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...
- San Jose, CA (21 miles from Soquel, CA)
- 30+ days ago
- San Jose, CA (21 miles from Soquel, CA)
- 30+ days ago
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market....
Demographic Data for Soquel, CA
Moving to Soquel, CA? Find some basic demographic data about Soquel, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Soquel, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Soquel, 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
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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