Regulatory Affairs Specialist Jobs in Mountain House, 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.
Product Regulatory Compliance Specialist
- Fremont, CA (24 miles from Mountain House, CA)
- 14 days ago
- Fremont, CA (24 miles from Mountain House, CA)
- 14 days ago
You will work directly with our engineering community, supply-chain management, and fellow product safety and environmental engineers to ensure evolving regulations are monitored, assessments of...
- Pleasanton, CA (15 miles from Mountain House, CA)
- 19 days ago
- Pleasanton, CA (15 miles from Mountain House, CA)
- 19 days 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...
Regulatory Compliance Specialist
- Livermore, CA (17 miles from Mountain House, CA)
- 30+ days ago
- Livermore, CA (17 miles from Mountain House, CA)
- 30+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
- Pleasanton, CA (15 miles from Mountain House, CA)
- 30+ days ago
- Pleasanton, CA (15 miles from Mountain House, CA)
- 30+ 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)...
Compliance Analyst, Senior (Operations)
- French Camp, CA (18 miles from Mountain House, CA)
- 60+ days ago
- French Camp, CA (18 miles from Mountain House, CA)
- 60+ days ago
The expected pay range is based on many factors such as geography, experience, education, and the market. The range is subject to change. We are hiring a Compliance Analyst, Senior (Operations) to...
Demographic Data for Mountain House, CA
Moving to Mountain House, CA? Find some basic demographic data about Mountain House, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Mountain House, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Mountain House, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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