Regulatory Affairs Specialist Jobs in Holly Springs, 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.
- Raleigh, NC (17 miles from Holly Springs, NC)
- 5 hours ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 5 hours 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)...
Plasma Regulatory Affairs Associate
- Raleigh, NC (17 miles from Holly Springs, NC)
- 8 hours ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 8 hours 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...
- Morrisville, NC (17 miles from Holly Springs, NC)
- 1 day ago
- Morrisville, NC (17 miles from Holly Springs, NC)
- 1 day 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: Responsible for...
Plasma Regulatory Affairs Associate
- Rtp, NC (21 miles from Holly Springs, NC)
- 2 days ago
- Rtp, NC (21 miles from Holly Springs, NC)
- 2 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...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days 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....
Finance and Business Compliance Analyst I
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days ago
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...
Governance, Risk & Compliance Analyst, Specialist
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 2 days ago
Recommends, develops, implements, and monitors enterprise-wide information security policies, procedures, and operational guidelines. Researches and develops solutions for information security...
- Raleigh, NC (17 miles from Holly Springs, NC)
- 7 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 7 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...
Senior Risk & Compliance Analyst
- Raleigh, NC (17 miles from Holly Springs, NC)
- 17 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 17 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...
- Raleigh, NC (17 miles from Holly Springs, NC)
- 17 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 17 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 (17 miles from Holly Springs, NC)
- 25 days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 25 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 (17 miles from Holly Springs, NC)
- 27 days ago
- Morrisville, NC (17 miles from Holly Springs, NC)
- 27 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...
- Raleigh, NC (17 miles from Holly Springs, NC)
- 30+ days ago
- Raleigh, NC (17 miles from Holly Springs, NC)
- 30+ days ago
Great Opportunity Starting in May 2025!! We are looking for a highly knowledgeable Risk Consultant for our Organizational Management Services client in Raleigh, NC. The Regulatory Compliance...
340B Program Compliance Analyst
- Morrisville, NC (17 miles from Holly Springs, NC)
- 30+ days ago
- Morrisville, NC (17 miles from Holly Springs, NC)
- 30+ 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 (22 miles from Holly Springs, NC)
- 60+ days ago
- Clayton, NC (22 miles from Holly Springs, NC)
- 60+ 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 Holly Springs, NC
Moving to Holly Springs, NC? Find some basic demographic data about Holly Springs, NC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Holly Springs, NC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Holly Springs, 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
- 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
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »