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...
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...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Raleigh, NC
- 1 day ago
- Raleigh, NC
- 1 day ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
RECRUITMENT RANE: $41,655 - $65,000 The purpose of this position is to participate in and assist the Monitoring andCompliance Unit with a variety of fiscal and administrative monitoring...
Recommends, develops, implements, and monitors enterprise-wide information security policies, procedures, and operational guidelines. Researches and develops solutions for information security...
audits and assessments to identify areas of improvement Provide guidance and support to internal stakeholders on trade compliance matters Stay updated with changes in trade regulations and communicate...
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...
At Equitable, our power is in our people. We're individuals from different cultures and backgrounds. Those differences make us stronger as a team and a force for good in our communities. Here,...
D.A. Davidson Companies is an independent, employee-owned company with a rich history spanning more than 80 years. We are dedicated to conducting our business in accordance with the highest...
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...
Demographic Data for North Carolina
Moving to North Carolina? Find some basic demographic data about North Carolina below.
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
- Medicare
- Internal Control
- Management Reporting
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Validation
- 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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