Regulatory Affairs Specialist Jobs in New Bremen, 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.
Company Description: Crown Equipment Corporation is a leading innovator in world-class forklift and material handling equipment and technology. As one of the worlds largest lift truck...
- Dayton, OH (24 miles from New Bremen, OH)
- 20 days ago
- Dayton, OH (24 miles from New Bremen, OH)
- 20 days ago
We help clients get work done more efficiently and economically, without compromising quality....
Remote Work- Dayton, OH (24 miles from New Bremen, OH)
- 29 days ago
- Dayton, OH (24 miles from New Bremen, OH)
- 29 days ago
The Compliance Analyst III is a professional compliance role responsible for supporting the Compliance program by focusing on areas of risk assessment to effectively stratify compliance risk,...
- Dayton, OH (24 miles from New Bremen, OH)
- 60+ days ago
- Dayton, OH (24 miles from New Bremen, OH)
- 60+ days ago
Overview Stable and growing organization Competitive weekly pay Professional, positive and people-centered work environment Fast-paced work environment Comprehensive benefits package: Health,...
Demographic Data for New Bremen, OH
Moving to New Bremen, OH? Find some basic demographic data about New Bremen, OH below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in New Bremen, OH
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in New Bremen, 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Risk Management
- Affirmative Action
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- 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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