Manager of Regulatory Affairs Jobs in North Carolina
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
management systems Advanced project management and organizational skills Excellent verbal and written communication abilities Effective negotiation and influencing skills Ability to work effectively...
In PersonRegulatory Affairs Manager (Transplant Diagnostics)
- Thermo Fisher Scientific
- NC
- 13 days ago
- NC
- 13 days ago
(k), PMA, CE marking, technical documentation) Strong knowledge of quality management systems (ISO 13485, GMP, QSR) Demonstrated success in regulatory strategy development and implementation Experience...
In PersonIdentifies and facilitates in the remedy of inefficiencies in Quality systems and processes....
In PersonSr. Regulatory Affairs Manager
- Validation & Engineering Group
- High Point, NC
- 20 days ago
- High Point, NC
- 20 days ago
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices...
In PersonMentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects. Provide regulatory strategy for the site consolidation and site transfers....
In PersonDirector, Regulatory Affairs Location: Remote Duration: 3 Months+ Description: Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs,...
Remote- Adecco USA, Inc.
- Morrisville, NC
- 30+ days ago
- Morrisville, NC
- 30+ days ago
Home Regulatory Affairs Director Healthcare & Life Sciences $ 114 - $ 117.50 / Hour location_on Morrisville, North Carolinapass_calibration Remote acute Contract/Temporary favorite_border JOB ON...
In PersonThe Manager of Regulatory Affairs is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and compliance with national and international regulatory...
In PersonDemographic Data for North Carolina
Moving to North Carolina? Find some basic demographic data about North Carolina below.
Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs in North Carolina
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in North Carolina offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- Product Launch
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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