Regulatory Affairs Specialist Jobs in Cary, NC
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.
Senior Compliance Analyst, Duals (D-SNP) Products
- Raleigh, NC (8 miles from Cary, NC)
- 12 days ago
- Raleigh, NC (8 miles from Cary, NC)
- 12 days ago
You could be the one who changes everything for our 28 million members. Centene is transforming the health of our communities, one person at a time. As a diversified, national organization, you'll...
- Raleigh, NC (8 miles from Cary, NC)
- 16 days ago
- Raleigh, NC (8 miles from Cary, NC)
- 16 days ago
. + 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 WorkRegulatory Compliance Specialist (Durham)
- Durham, NC (17 miles from Cary, NC)
- 22 days ago
- Durham, NC (17 miles from Cary, NC)
- 22 days ago
Prepare for and coordinate regulatory and internal audit compliance examinations and inform the Compliance Manager of audit results....
Plasma Regulatory Affairs Associate
- Raleigh, NC (8 miles from Cary, NC)
- 24 days ago
- Raleigh, NC (8 miles from Cary, NC)
- 24 days ago
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...
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Plasma Regulatory Affairs Associate
- Rtp, NC (11 miles from Cary, NC)
- 26 days ago
- Rtp, NC (11 miles from Cary, NC)
- 26 days ago
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...
- Raleigh, NC (8 miles from Cary, NC)
- 30+ days ago
- Raleigh, NC (8 miles from Cary, NC)
- 30+ days ago
We are seeking a Pay Compensation Analyst based at our headquarters in Raleigh, NC who will report directly to the Director of Compensation. The Pay Compliance Analyst will provide consultative...
- Raleigh, NC (8 miles from Cary, NC)
- 45+ days ago
- Raleigh, NC (8 miles from Cary, NC)
- 45+ days ago
Join Bell Partners and be a difference maker. At Bell Partners, our mission is to be the apartment company of choice by creating value and honoring commitments to our residents, partners, and...
Regulatory Compliance Specialist
- Morrisville, NC (7 miles from Cary, NC)
- 45+ days ago
- Morrisville, NC (7 miles from Cary, NC)
- 45+ days ago
Career Opportunities: Regulatory Compliance Specialist (9891) Requisition ID 9891 - Posted 03/18/2025 - United States - Morrisville - Product Management - Nufarm - Crop Protection Grow a Better...
340B Program Compliance Analyst
- Morrisville, NC (7 miles from Cary, NC)
- 60+ days ago
- Morrisville, NC (7 miles from Cary, NC)
- 60+ days ago
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: This position...
Senior Regulatory Affairs Specialist
- Clayton, NC (20 miles from Cary, NC)
- 90+ days ago
- Clayton, NC (20 miles from Cary, NC)
- 90+ days ago
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 Cary, NC
Moving to Cary, NC? Find some basic demographic data about Cary, NC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cary, NC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cary, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Reimbursement
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- 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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