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.
Senior Compliance Analyst - Enhanced Due Diligence (Remote)
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 days ago
Overview The Senior Compliance Analyst is part of FCB Financial Intelligence Unit’s Due Diligence Group team with the specific responsibilities of assessing and managing client BSA/AML risks both...
Remote WorkEnvironmental Planning and Compliance Analyst-Water Resource Planning
- Durham, NC (10 miles from Morrisville, NC)
- 3 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 3 days ago
Work, Serve, Thrive. With the City of Durham Advance in your career while making a real difference in the community you serve. Hiring Range: $65,749 $83,845 Hours: 8:00 a.m. - 5:00 p.m. flexible...
Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred)
- Raleigh, NC (11 miles from Morrisville, NC)
- 3 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 3 days ago
Corza Medical Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) in Raleigh , North Carolina Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) Location...
Cybersecurity Senior PAM Compliance Analyst
- Raleigh, NC (11 miles from Morrisville, NC)
- 6 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 6 days ago
The position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to...
- Research Triangle Park, NC (4 miles from Morrisville, NC)
- 7 days ago
- Research Triangle Park, NC (4 miles from Morrisville, NC)
- 7 days ago
Job Summary: As a NetApp Senior SOX (Sarbanes Oxley) Analyst, you are part of a team of professionals who plans, performs and implements process improvement initiatives for the Finance SOX...
Remote IT Quality Assurance and Compliance, Analyst
- Raleigh, NC (11 miles from Morrisville, NC)
- 7 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 7 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Raleigh , North Carolina Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and...
Remote WorkDescription 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...
- Raleigh, NC (11 miles from Morrisville, NC)
- 11 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 11 days ago
Overview The CRG Compliance Analyst is responsible for remaining well-informed of the regulations that the Retail, Mortgage and Recovery Credit Resolution Department must remain in compliance...
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Raleigh, NC (11 miles from Morrisville, NC)
- 11 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 11 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote WorkSpecialist, Regulatory Affairs
- Durham, NC (10 miles from Morrisville, NC)
- 17 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 17 days ago
Job Description 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...
IT Governance and Compliance Analyst
- Durham, NC (10 miles from Morrisville, NC)
- 17 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 17 days ago
We are currently seeking an experienced highly motivated individual to join Pearson as our IT Audit Analyst - SOX Compliance. This position reports to the Manager, IT Governance and Compliance,...
NAM ESG Regulatory Compliance Specialist
- Raleigh, NC (11 miles from Morrisville, NC)
- 45+ days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 45+ days ago
Description General Information: Hitachi Energy offers power and automation products, systems and service solutions across the generation, transmission and distribution value chain - enabling a...
- Raleigh, NC (11 miles from Morrisville, NC)
- 45+ days ago
- Raleigh, NC (11 miles from Morrisville, 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...
Sr Specialist, Regulatory Affairs
- Holly Springs, NC (17 miles from Morrisville, NC)
- 90+ days ago
- Holly Springs, NC (17 miles from Morrisville, NC)
- 90+ days ago
System software and general IT savviness....
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
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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