Regulatory Affairs Specialist Jobs in Elk Grove, 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.
- Sacramento, CA (14 miles from Elk Grove, CA)
- 2 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 2 days ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Transactions Compliance Analyst - Hybrid
- Sacramento, CA (14 miles from Elk Grove, CA)
- 6 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 6 days ago
and Duties This position is located in Sacramento. At HCD, we are dedicated to fostering a dynamic and inclusive work environment where innovation and collaboration thrive. If youre interested in...
Health Records Compliance Analyst - Remote - Nationwide
- Sacramento, CA (14 miles from Elk Grove, CA)
- 7 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 7 days ago
Remote, Nationwide – Seeking Health Records Compliance Analyst Everybody Has A Role To Play In Transforming Healthcare At Vituity you are part of a larger team that is driven by our purpose to...
Remote Work- Sacramento, CA (14 miles from Elk Grove, CA)
- 8 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 8 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Community Services Specialist Quality Assurance and Compliance Specialist
- Sacramento, CA (14 miles from Elk Grove, CA)
- 9 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 9 days ago
THE ORGANIZATION Alta California Regional Center (ACRC) is a non-profit agency under contract to the State of California and for 50 years has provided the coordination of services to individuals...
- Sacramento, CA (14 miles from Elk Grove, CA)
- 18 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 18 days ago
Classification: Represented by SHRA Employee Association Under limited supervision, to provide a wide variety of technical and analytical support to ensure that borrowers of Agency funds are in...
Senior Risk & Compliance Analyst
- Sacramento, CA (14 miles from Elk Grove, CA)
- 19 days ago
- Sacramento, CA (14 miles from Elk Grove, CA)
- 19 days ago
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
340B Program Compliance Analyst
- Roseville, CA (20 miles from Elk Grove, CA)
- 90+ days ago
- Roseville, CA (20 miles from Elk Grove, CA)
- 90+ days ago
Conducts internal audits for 340B program compliance. Identifies gaps in program performance and assists in development of action plans to resolve identified issues....
Demographic Data for Elk Grove, CA
Moving to Elk Grove, CA? Find some basic demographic data about Elk Grove, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Elk Grove, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Elk Grove, 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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