Regulatory Affairs Specialist Jobs in Cincinnati, 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.
- Covington, KY (7 miles from Cincinnati, OH)
- 1 day ago
- Covington, KY (7 miles from Cincinnati, OH)
- 1 day ago
Associate Compliance Analyst - eMonitoring As a member of the Social Media and eCommunications team, the Associate Compliance Analyst has the responsibility of reviewing and acting on all alerted...
- Covington, KY (7 miles from Cincinnati, OH)
- 3 days ago
- Covington, KY (7 miles from Cincinnati, OH)
- 3 days ago
Associate Compliance Analyst - eMonitoring As a member of the Social Media and eCommunications team, the Associate Compliance Analyst has the responsibility of reviewing and acting on all alerted...
Responsible for the management of a wide range of data, including gathering, analyzing and summarizing data necessary for Health & Wellness compliance, quality related activities, and continuous...
system requirements including 21 CFR 820, ISO13485, 98/79 EC, and SOR/98-282 Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical...
- Hamilton, OH (18 miles from Cincinnati, OH)
- 90+ days ago
- Hamilton, OH (18 miles from Cincinnati, OH)
- 90+ days ago
The Compliance Analyst will lead and support quality and food safety compliance for a manufacturing site. This position will conduct facility inspections, auditing internal and external sites, and...
Demographic Data for Cincinnati, OH
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cincinnati, OH
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cincinnati, 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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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