Regulatory Affairs Specialist Jobs in Manchester, NY
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.
- Rochester, NY (23 miles from Manchester, NY)
- 15 days ago
- Rochester, NY (23 miles from Manchester, NY)
- 15 days ago
Internal Audits: Participate in or conduct internal audits to ensure that the company is operating in compliance with relevant regulations....
Corporate Regulatory Compliance Specialist
- Rochester, NY (23 miles from Manchester, NY)
- 23 days ago
- Rochester, NY (23 miles from Manchester, NY)
- 23 days ago
Corporate Regulatory Compliance Specialist Rochester, NY ( Description For over a century, American Packaging Corporation (APC) has been a leading flexible packaging converter for customers...
Lead Contract Compliance Analyst
- Rochester, NY (23 miles from Manchester, NY)
- 60+ days ago
- Rochester, NY (23 miles from Manchester, NY)
- 60+ days ago
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness,...
Compliance Analyst I - Remote Hybrid Opportunity
- Rochester, NY (23 miles from Manchester, NY)
- 60+ days ago
- Rochester, NY (23 miles from Manchester, NY)
- 60+ days ago
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness,...
Demographic Data for Manchester, NY
Moving to Manchester, NY? Find some basic demographic data about Manchester, NY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Manchester, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Manchester, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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