Regulatory Affairs Specialist Jobs in Menlo Park, 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.
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 1 day ago
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 1 day ago
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
Cybersecurity Risk and Compliance Analyst
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 1 day ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 1 day 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 (18 miles from Menlo Park, CA)
- 2 days ago
- San Jose, CA (18 miles from Menlo Park, CA)
- 2 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...
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
Senior Regulatory Affairs Specialist
- Redwood City, CA (3 miles from Menlo Park, CA)
- 3 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 3 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 (20 miles from Menlo Park, CA)
- 3 days ago
- Milpitas, CA (20 miles from Menlo Park, CA)
- 3 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 (10 miles from Menlo Park, CA)
- 11 days ago
- Sunnyvale, CA (10 miles from Menlo Park, CA)
- 11 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...
Principal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 13 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 13 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)....
Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (20 miles from Menlo Park, CA)
- 13 days ago
- Milpitas, CA (20 miles from Menlo Park, CA)
- 13 days ago
Summary As Regulatory Affairs Specialist, you will be working in the BD Biosciences Unit on IVD devices with a focus on meeting sustaining IVDR requirements with guidance from the Regulatory Affairs...
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 14 days ago
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 14 days ago
IT SOX Compliance Analyst 1917 A leading enterprise software solutions company is seeking an IT SOX Compliance Analyst. The successful candidate will support audit and Sarbanes-Oxley (SOX)...
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 16 days ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 16 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 (14 miles from Menlo Park, CA)
- 16 days ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 16 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....
Principal Regulatory Affairs Specialist (Business Partnerships).
- Alameda, CA (22 miles from Menlo Park, CA)
- 16 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 16 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)....
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 16 days ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 16 days ago
Device Regulatory Affairs Associate Regulatory Affairs Regulatory Regulatory Affairs Specialist Quality Compliance CAPA change management change order FDA Biotechnology Pharmaceuticals Medical Device...
Senior Regulatory Affairs Specialist
- Sunnyvale, CA (10 miles from Menlo Park, CA)
- 21 days ago
- Sunnyvale, CA (10 miles from Menlo Park, 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...
Demographic Data for Menlo Park, CA
Moving to Menlo Park, CA? Find some basic demographic data about Menlo Park, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Menlo Park, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Menlo Park, 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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