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.
- Durham, NC (10 miles from Morrisville, NC)
- 3 hours ago
- Durham, NC (10 miles from Morrisville, NC)
- 3 hours ago
Participate in internal audits, compliance reviews, and other activities to evaluate the effectiveness of organizational compliance controls....
- Durham, NC (10 miles from Morrisville, NC)
- 2 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 2 days ago
Part Time 5943 At Wolfspeed, we do amazing things in a human way. We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate...
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 2 days ago
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkBusiness Intelligence and Compliance Analyst- REMOTE
- Raleigh, NC (11 miles from Morrisville, NC)
- 10 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 10 days ago
Job Seekers can review the Job Applicant Privacy Policy by clicking here ( ). Job Description : Summary The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote Work- Raleigh, NC (11 miles from Morrisville, NC)
- 16 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 16 days ago
Job Details Job Location : Raleigh Office - Raleigh, NC Salary Range : Undisclosed Description The Conflict Compliance Analyst assists the Conflict Compliance Manager in their day-to-day work,...
- Durham, NC (10 miles from Morrisville, NC)
- 16 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 16 days ago
Knowledge of FDA regulations relevant to labeling and XML labeling. Proficient with computer software applications and medical terminology. Ability to negotiate solutions to labeling issues....
- Durham, NC (10 miles from Morrisville, NC)
- 45+ days ago
- Durham, NC (10 miles from Morrisville, NC)
- 45+ days ago
Part-Time Regulatory Affairs Specialist Location: Durham, NC (Hybrid) Industry: Flavor, Fragrance, Food, Brewing, Distilling, Confectionery, Nutraceutical Schedule: Monday-Friday 8am-5pm, flexible to...
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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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