Regulatory Affairs Specialist Jobs in Citrus Heights, 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.
Community Services Specialist Quality Assurance and Compliance Specialist
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 1 day ago
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 1 day 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 Citrus Heights, CA)
- 5 days ago
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 5 days ago
Essential Responsibilities Lead and conduct HR internal audits and tracers for The Joint Commission, FTCA, and HRSA. Will also participate in an external contract, and county and state audits....
Senior Risk & Compliance Analyst
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 8 days ago
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 8 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Regulatory Affairs Specialist - Post Market
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 30+ days ago
- Sacramento, CA (14 miles from Citrus Heights, CA)
- 30+ days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote Work340B Program Compliance Analyst, Pharmacy
- Roseville, CA (3 miles from Citrus Heights, CA)
- 60+ days ago
- Roseville, CA (3 miles from Citrus Heights, CA)
- 60+ 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 Citrus Heights, CA
Moving to Citrus Heights, CA? Find some basic demographic data about Citrus Heights, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Citrus Heights, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Citrus Heights, 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
- Cross-Functional Team 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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