Regulatory Affairs Specialist Jobs in Morrisville, 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.
Finance & Business Compliance Analyst
- Raleigh, NC (11 miles from Morrisville, NC)
- 17 hours ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 17 hours ago
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...
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 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 Work- Cary, NC (7 miles from Morrisville, NC)
- 2 days ago
- Cary, NC (7 miles from Morrisville, NC)
- 2 days ago
Insight 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...
Regulatory Compliance Specialist (Durham)
- Durham, NC (10 miles from Morrisville, NC)
- 8 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 8 days ago
Prepare for and coordinate regulatory and internal audit compliance examinations and inform the Compliance Manager of audit results....
- Raleigh, NC (11 miles from Morrisville, NC)
- 10 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 10 days 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 (11 miles from Morrisville, NC)
- 11 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 11 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...
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 (4 miles from Morrisville, NC)
- 12 days ago
- Rtp, NC (4 miles from Morrisville, NC)
- 12 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 (11 miles from Morrisville, NC)
- 18 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 18 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 (11 miles from Morrisville, NC)
- 27 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 27 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 (11 miles from Morrisville, NC)
- 28 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 28 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 (11 miles from Morrisville, NC)
- 30+ days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 30+ 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...
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 (11 miles from Morrisville, NC)
- 30+ days ago
- Raleigh, NC (11 miles from Morrisville, 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...
Senior Specialist, Regulatory Affairs (Hybrid)
- Durham, NC (10 miles from Morrisville, NC)
- 30+ days ago
- Durham, NC (10 miles from Morrisville, NC)
- 30+ days ago
Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small...
Demographic Data for Morrisville, NC
Moving to Morrisville, NC? Find some basic demographic data about Morrisville, NC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morrisville, NC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morrisville, 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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