Regulatory Affairs Specialist Jobs in Durham, 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.
HCS Compliance Analyst II - Physician Compliance
- UNC Health Care Systems
- Morrisville, NC (10 miles from Durham, NC)
- 3 days ago
- Morrisville, NC (10 miles from Durham, NC)
- 3 days ago
Description Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina. Summary:...
In PersonHCS Compliance Analyst II - Hospital Compliance
- UNC Health Care Systems
- Morrisville, NC (10 miles from Durham, NC)
- 4 days ago
- Morrisville, NC (10 miles from Durham, NC)
- 4 days ago
Job Description Description Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North...
In PersonPlasma Regulatory Affairs Associate Grifols - 3.0 Durham, NC Job Details Full-time 1 day ago Qualifications Research Full Job Description Would you like to join an international team working to...
In PersonPlasma Regulatory Affairs Associate
- Grifols SA
- Raleigh, NC (21 miles from Durham, NC)
- 18 days ago
- Raleigh, NC (21 miles from Durham, NC)
- 18 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...
In Person- Ascensus
- Raleigh, NC (21 miles from Durham, NC)
- 19 days ago
- Raleigh, NC (21 miles from Durham, NC)
- 19 days ago
Ascensus is the leading independent technology and service platform powering savings plans across America, providing products and expertise that help nearly 16 million people save for a better...
In PersonPlasma Regulatory Affairs Associate 1
- Grifols
- Rtp, NC (6 miles from Durham, NC)
- 20 days ago
- Rtp, NC (6 miles from Durham, NC)
- 20 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...
In PersonThe Sr Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits....
In PersonRegulatory Affairs Associate/Senior Associate
- Azurity Pharmaceuticals
- Raleigh, NC (21 miles from Durham, NC)
- 60+ days ago
- Raleigh, NC (21 miles from Durham, NC)
- 60+ days ago
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
HybridDemographic Data for Durham, NC
Moving to Durham, NC? Find some basic demographic data about Durham, NC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Durham, NC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Durham, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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