Regulatory Affairs Specialist Jobs in Alpharetta, 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.
- Childrens Healthcare of Atlanta
- Brookhaven, GA (17 miles from Alpharetta, GA)
- 5 days ago
- Brookhaven, GA (17 miles from Alpharetta, GA)
- 5 days ago
Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Day...
In PersonCompliance 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 (14 miles from Alpharetta, GA)
- 20 days ago
- Peachtree Corners, GA (14 miles from Alpharetta, 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 PersonSenior Supply Chain Compliance Analyst
- NISSAN MOTOR CO LTD
- Smyrna, GA (21 miles from Alpharetta, GA)
- 29 days ago
- Smyrna, GA (21 miles from Alpharetta, GA)
- 29 days ago
Location: Smyrna, TN Job Schedule: Full-time, Hybrid (4 days in office) Education Requirement: Bachelor's degree; MBA is a plus. Sponsorship: No Come Drive Innovation with Us. We are currently...
In Person Full TimeTrade Compliance Analyst - Trade Programs
- Intuitive
- Peachtree Corners, GA (14 miles from Alpharetta, GA)
- 60+ days ago
- Peachtree Corners, GA (14 miles from Alpharetta, 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 Personaudit 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 PersonQuality Assurance and Compliance Specialist
- Revelation Pharma
- Kennesaw, GA (18 miles from Alpharetta, GA)
- 60+ days ago
- Kennesaw, GA (18 miles from Alpharetta, GA)
- 60+ days ago
Prepare audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans. Host and/or assist departments in preparing for external inspections....
In PersonRegulatory Affairs Specialist (NMPA)
- Intuitive
- Peachtree Corners, GA (14 miles from Alpharetta, GA)
- 90+ days ago
- Peachtree Corners, GA (14 miles from Alpharetta, 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 Alpharetta, GA
Moving to Alpharetta, GA? Find some basic demographic data about Alpharetta, GA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Alpharetta, GA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Alpharetta, 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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