Regulatory Affairs Specialist Jobs in Columbia Station, OH
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.
- Westlake, OH (9 miles from Columbia Station, OH)
- 6 days ago
- Westlake, OH (9 miles from Columbia Station, OH)
- 6 days ago
About Goosehead Since 2003, Goosehead Insurance has been disrupting the insurance industry by giving clients the power of choice, utilizing a smarter marketing approach, and delivering world-class...
- Brecksville, OH (16 miles from Columbia Station, OH)
- 25 days ago
- Brecksville, OH (16 miles from Columbia Station, OH)
- 25 days ago
Act as lead for self-audits and internal audits including identifying and implementing corrective action....
- Brecksville, OH (16 miles from Columbia Station, OH)
- 60+ days ago
- Brecksville, OH (16 miles from Columbia Station, OH)
- 60+ days ago
Knowledge of European, ISO 13485 and FDA regulations preferred. Knowledge of international regulatory guidelines regarding GMP requirements is desirable....
Demographic Data for Columbia Station, OH
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Columbia Station, OH
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Columbia Station, OH offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Engineering
- Risk Management
- Affirmative Action
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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