Regulatory Affairs Specialist Jobs in North Carolina
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.
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Are you passionate about the environment and want to make a difference? DEQ has an open opportunity for a Finance and Business Compliance Analyst II. This position is Exempt from the Human...
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkInsight Global's client is seeking an IT Compliance Analyst. This position may focus on technical or administrative aspects of IT compliance and IT risks for IT/Information Security areas, or...
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for...
Prepare for and coordinate regulatory and internal audit compliance examinations and inform the Compliance Manager of audit results....
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can...
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since...
Description Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary: Responsible for...
Audit to assist with compliance audits and planning Identifies and report discrepancies or violations, ensuring timely resolution Provides oversight, training, and support to Association staff to ensure...
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since...
Demographic Data for North Carolina
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in North Carolina
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in North Carolina 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Military Background
- 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
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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