Regulatory Affairs Specialist Jobs in Garner, 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.
340B Program Compliance Analyst
- Morrisville, NC (20 miles from Garner, NC)
- 2 days ago
- Morrisville, NC (20 miles from Garner, NC)
- 2 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 Compliance Analyst (Risk Assessment and Oversight) - Remote
- Raleigh, NC (9 miles from Garner, NC)
- 3 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 3 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...
Remote WorkSenior Compliance Analyst, Duals (D-SNP) Products
- Raleigh, NC (9 miles from Garner, NC)
- 3 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 3 days ago
You could be the one who changes everything for our 28 million members. Centene is transforming the health of our communities, one person at a time. As a diversified, national organization, youll...
- Raleigh, NC (9 miles from Garner, NC)
- 4 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 4 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 WorkSenior Data & Compliance Analyst
- Raleigh, NC (9 miles from Garner, NC)
- 8 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 8 days ago
Senior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
- Raleigh, NC (9 miles from Garner, NC)
- 28 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 28 days ago
Compliance Analyst Salary $41,655.00 - $66,833.00 Annually Location Wake County, NC Job Type Permanent Full-Time Remote Employment Flexible/Hybrid Job Number 25-06288 OCI65040417 Department Dept...
- Raleigh, NC (9 miles from Garner, NC)
- 28 days ago
- Raleigh, NC (9 miles from Garner, NC)
- 28 days ago
Compliance Analyst II Salary $45,926.00 - $73,682.00 Annually Location Wake County, NC Job Type Permanent Full-Time Remote Employment Flexible/Hybrid Job Number 25-06290 OCI65040425 Department...
- Raleigh, NC (9 miles from Garner, NC)
- 60+ days ago
- Raleigh, NC (9 miles from Garner, NC)
- 60+ 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...
Senior Regulatory Affairs Specialist
- Clayton, NC (6 miles from Garner, NC)
- 90+ days ago
- Clayton, NC (6 miles from Garner, NC)
- 90+ 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 (9 miles from Garner, NC)
- 60+ days ago
- Raleigh, NC (9 miles from Garner, NC)
- 60+ 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...
Demographic Data for Garner, NC
Moving to Garner, NC? Find some basic demographic data about Garner, NC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Garner, NC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Garner, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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