Regulatory Affairs Specialist Jobs in Aurora, OH
Sr Regulatory Affairs Specialist
- Hudson, OH (7 miles from Aurora, OH)
- 9 days ago
- Hudson, OH (7 miles from Aurora, OH)
- 9 days ago
Primary Responsibilities Regulatory Submissions & Strategy Prepare, review, and submit regulatory documents including FDA 510(k), PMA, De Novo, pre-submissions and EU MDR technical files....
Remote Work- Beachwood, OH (14 miles from Aurora, OH)
- 11 days ago
- Beachwood, OH (14 miles from Aurora, OH)
- 11 days ago
Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose...
GEHC - Regulatory Affairs Specialists III
- Beachwood, OH (14 miles from Aurora, OH)
- 11 days ago
- Beachwood, OH (14 miles from Aurora, OH)
- 11 days ago
Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose...
Trade Compliance Analyst II (Brecksville, OH, US, 44141-3247)
- Brecksville, OH (14 miles from Aurora, OH)
- 20 days ago
- Brecksville, OH (14 miles from Aurora, OH)
- 20 days ago
Act as lead for self-audits and internal audits including identifying and implementing corrective action....
- Brecksville, OH (14 miles from Aurora, OH)
- 21 days ago
- Brecksville, OH (14 miles from Aurora, OH)
- 21 days ago
Act as lead for self-audits and internal audits including identifying and implementing corrective action....
Demographic Data for Aurora, OH
Moving to Aurora, OH? Find some basic demographic data about Aurora, OH below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Aurora, OH
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Aurora, OH 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
- ICH Guidelines
- 21 CFR 820
- Institutional Review Board
- ISO 13485
- Quality Systems
- Quality Management Systems
- Validation
- Medical Device Sales
- Microsoft Visio
- FDA Regulations
- Corrective Actions & Preventive Actions
- Root Cause Analysis
- Microsoft SharePoint
- Standard Operating Procedures
- Product Development
- Strategy Development
- Reimbursement
- Risk Management
- Engineering
- Military Background
- Analytical Skills
- Written Communication
- Implementation
- Auditing
- Process Improvement
- Microsoft Outlook
- Documentation
- Verbal Communication
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Regulations
- Filing
- Education Experience
- Project Management
- Time Management
- Research Skills
- Microsoft Office
- Sales
- Computer Skills
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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