Regulatory Affairs Specialist Jobs in Cumming, GA
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.
- LX Hausys America, Inc.
- Alpharetta, GA (12 miles from Cumming, GA)
- 16 days ago
- Alpharetta, GA (12 miles from Cumming, GA)
- 16 days ago
Compliance Analyst Available in Alpharetta, GA. Job Duties Evaluate and maintain the companys internal control and compliance framework to ensure compliance with U.S. SOX and Korean Sarbanes-Oxley...
In PersonExport Customs Compliance Analyst
- Intuitive
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 20 days ago
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 20 days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In Person- Wayne-Sanderson Farms
- Oakwood, GA (20 miles from Cumming, GA)
- 23 days ago
- Oakwood, GA (20 miles from Cumming, GA)
- 23 days ago
Regulatory Affairs Specialist About the Role The Regulatory Affairs Specialist plays a critical role in ensuring our products meet USDA and other regulatory requirements, while also supporting product...
In PersonTrade Compliance Analyst - Trade Programs
- Intuitive
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 60+ days ago
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 60+ days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In Person- Hunt Companies, Inc.
- Alpharetta, GA (12 miles from Cumming, GA)
- 60+ days ago
- Alpharetta, GA (12 miles from Cumming, GA)
- 60+ days ago
audit Required 1-3 years experience with rootcause analysis and corrective action followthrough Required 1-3 years Yardi proficiency Preferred PM/CMMS familiarity Preferred Maintenance acumen; analytical...
In PersonRegulatory Affairs Specialist (NMPA)
- Intuitive
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 90+ days ago
- Peachtree Corners, GA (24 miles from Cumming, GA)
- 90+ days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In PersonDemographic Data for Cumming, GA
Moving to Cumming, GA? Find some basic demographic data about Cumming, GA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cumming, GA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cumming, GA 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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