Regulatory Affairs Specialist Jobs in Half Moon Bay, 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.
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA (22 miles from Half Moon Bay, CA)
- 60+ days ago
- Alameda, CA (22 miles from Half Moon Bay, CA)
- 60+ days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
- San Francisco, CA (21 miles from Half Moon Bay, CA)
- 8 hours ago
- San Francisco, CA (21 miles from Half Moon Bay, CA)
- 8 hours ago
HealthRIGHT 360 gives hope, builds health, and changes lives for people in need by providing comprehensive, integrated, compassionate care that includes primary medical care, mental health...
Security & Compliance Analyst II
- San Francisco, CA (21 miles from Half Moon Bay, CA)
- 2 days ago
- San Francisco, CA (21 miles from Half Moon Bay, CA)
- 2 days ago
About the INSERT ROLE TITLE at Headspace: What you will do: Etc Etc Etc Etc Etc What you will bring: Required Skills: * Preferred Skills: * Location: This is a hybrid role located in our [San...
Staff Global Trade Compliance Analyst
- Hayward, CA (22 miles from Half Moon Bay, CA)
- 2 days ago
- Hayward, CA (22 miles from Half Moon Bay, CA)
- 2 days ago
Tesla is seeking a highly motivated Global Trade Professional to join its Trade Team. The Trade Team supports all Import/Export Operations globally and is responsible for Tesla's Trade Compliance...
Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
- Sunnyvale, CA (22 miles from Half Moon Bay, CA)
- 3 days ago
- Sunnyvale, CA (22 miles from Half Moon Bay, 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...
Regulatory Operations Specialist - Temporary
- South San Francisco, CA (12 miles from Half Moon Bay, CA)
- 4 days ago
- South San Francisco, CA (12 miles from Half Moon Bay, CA)
- 4 days ago
Ability to travel 5% Follow regulatory and ISO 13485 requirements....
- Palo Alto, CA (14 miles from Half Moon Bay, CA)
- 4 days ago
- Palo Alto, CA (14 miles from Half Moon Bay, CA)
- 4 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...
Expert Risk & Compliance Analyst
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 7 days ago
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 7 days ago
Requisition ID # 166173 Job Category: Compliance / Risk / Quality Assurance Job Level: Individual Contributor Business Unit: Gen Counsel, Ethics, Risk & Compliance Work Type: Hybrid Job Location:...
Principal Risk & Compliance Analyst
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 7 days ago
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 7 days ago
Requisition ID # 166259 Job Category: Compliance / Risk / Quality Assurance Job Level: Manager/Principal Business Unit: Gen Counsel, Ethics, Risk & Compliance Work Type: Hybrid Job Location:...
Senior Regulatory Affairs Specialist
- Redwood City, CA (9 miles from Half Moon Bay, CA)
- 8 days ago
- Redwood City, CA (9 miles from Half Moon Bay, CA)
- 8 days ago
Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices....
- Palo Alto, CA (14 miles from Half Moon Bay, CA)
- 11 days ago
- Palo Alto, CA (14 miles from Half Moon Bay, CA)
- 11 days ago
Position Overview: We are seeking an experienced SOX Compliance & GRC Analyst to lead our SOX IT General Controls program while supporting our broader governance, risk, and compliance initiatives....
Regulatory Affairs Specialist, NPD
- Sunnyvale, CA (22 miles from Half Moon Bay, CA)
- 13 days ago
- Sunnyvale, CA (22 miles from Half Moon Bay, 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...
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 17 days ago
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 17 days ago
Compliance Analyst Oakland, CA Approximate contract length is 5+ Months ONLY SUBMIT CANDIDATES CURRENTLY RESIDING IN BAY AREA/NEAR WORK LOCATION-OAKLAND. ASSIGMENT IS HYBRID AND REQUIRED...
Compliance Analyst/ Senior Compliance Consultant
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 17 days ago
- Oakland, CA (23 miles from Half Moon Bay, CA)
- 17 days ago
**********LOCAL CANDIDATES ONLY***NO C2C*************** Title Compliance Analyst Location - Oakland, CA (hybrid) Pay Range: 60k -77k/annum Job id - 3312 Description: LOOKING FOR CANDIDATES...
Principal International Regulatory Affairs Associate
- Cupertino, CA (21 miles from Half Moon Bay, CA)
- 21 days ago
- Cupertino, CA (21 miles from Half Moon Bay, 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....
Demographic Data for Half Moon Bay, CA
Moving to Half Moon Bay, CA? Find some basic demographic data about Half Moon Bay, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Half Moon Bay, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Half Moon Bay, 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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