Regulatory Affairs Specialist Jobs in Randolph, OH
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1 Jobs
Sr Regulatory Affairs Specialist
- Hudson, OH (18 miles from Randolph, OH)
- 9 days ago
- Hudson, OH (18 miles from Randolph, 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 WorkRegulatory Affairs Specialist Online Courses and Training Opportunities
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Regulatory Affairs: CMC
This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC...
Drug Regulatory Affair
OverviewDrug Regulatory Affairs (DRA) is a field that involves the study and implementation of regulations, guidelines, and laws related to the development, production, and marketing of...
Regulatory affairs CTD course
Section 1-Regulatory affairs profesion -organization of different departments in pharmaceutical industry -Introduction to Common Technical Document (CTD)-Background on ICH guidance and CTD-Basic...
Salary for Regulatory Affairs Specialist Jobs in Randolph, OH
Estimated salary range based on data from US Bureau of Labor Statistics (BLS) and iHire research efforts.
Licensing / Certification
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Randolph, OH offer the following education background
Master's Degree
40.3%
Bachelor's Degree
39.4%
Doctorate Degree
8.5%
Associate's Degree
4.9%
Vocational Degree or Certification
3.3%
High School or GED
3.1%
Some College
0.5%
Average Work Experience
Here's a breakdown of the number of years' experience offered by Regulatory Affairs Specialists in Randolph, OH
2-4 years
55.0%
1-2 years
25.0%
4-6 years
10.0%
Less than 1 year
5.0%
None
5.0%
Qualifications / 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
- Continuous Improvement
- 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
- Computer Skills
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
In-Demand skills () are the most popular among employers according to the current jobs in our database. Last updated today!
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