Regulatory Affairs Specialist Jobs in North Carolina
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.
Prepare materials for internal audits, regulatory exams, and executive reporting that clearly communicate the health and effectiveness of the channel partner compliance program....
In PersonProvide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions....
In PersonHCS Compliance Analyst II - Physician Compliance
- UNC Health Care Systems
- Morrisville, NC
- 3 days ago
- Morrisville, 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
- 4 days ago
- Morrisville, 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 Personaudits, including walkthroughs and remediation follow-up Collaborate with cross-functional teams to gather and verify compliance information What We're Looking For: Required Qualifications Bachelor's...
In PersonAbout the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of...
In PersonLOC/DC Regulatory Compliance Specialist
- 6032-DePuy Synthes Sales, Inc. Legal Entity
- Mooresville, NC
- 7 days ago
- Mooresville, NC
- 7 days ago
policies, and quality system standards across LOC/DC operations....
HybridDentsply Sirona Keyword Location Search view all jobs Regulatory Affairs Specialist York, PA Posted 3 days ago Apply Now Requistion ID : 83371 Dentsply Sirona is the world's largest manufacturer of...
In PersonSenior Regulatory Affairs Consultant - Ad Promo
- 1010 Parexel International, LLC
- NC
- 13 days ago
- NC
- 13 days ago
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market...
In PersonTrade Compliance Analyst - Atlas Copco India
- Atlas Copco (India) Ltd.
- Charlotte, NC
- 13 days ago
- Charlotte, NC
- 13 days ago
Trade Compliance Analyst Apply now Your role As the Trade Compliance Analyst you will support the Trade Compliance Manager by delivering critical analytical insights, aiding in day-to-day trade...
HybridTalent Acquisition Compliance Analyst
- Coca-Cola Bottling Co. Consolidated
- Charlotte, NC
- 13 days ago
- Charlotte, NC
- 13 days ago
Requisition ID: 255571 Locations: Charlotte Click here to experience a Day in the Life of our Teammates! Uncap Your Potential at America's Largest Coca-Cola Bottler - Pour Your Passion into...
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 Personaudits to ensure compliance with import regulations and company policies Oversee customs broker relationships to ensure accurate and timely customs clearance Maintain thorough knowledge of 19 CFR and...
HybridWould 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 PersonWhere Ambition Meets Innovation Build a career that matches all your initiative with an impressive dose of innovation. From cutting-edge resources and a collaborative environment to the freedom to...
In PersonDemographic Data for North Carolina
Moving to North Carolina? Find some basic demographic data about North Carolina below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in North Carolina
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in North Carolina 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
- Systems Applications & Products
- 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
- Sales
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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