Regulatory Affairs Specialist Jobs in Huntington, 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.
Compliance Analyst, 340B Program
- Valhalla, NY (24 miles from Huntington, NY)
- 3 days ago
- Valhalla, NY (24 miles from Huntington, NY)
- 3 days ago
Job Summary: The 340B Program Compliance Analyst is responsible for maintaining regulatory compliance within the 340B Program across all WMCHealth entities. This role ensures adherence to HRSA...
Sr. Regulatory Compliance Specialist
- Farmingdale, NY (9 miles from Huntington, NY)
- 21 days ago
- Farmingdale, NY (9 miles from Huntington, NY)
- 21 days ago
Coordinate the current Good Manufacturing Practice (cGMP) compliance efforts for pharmaceutical manufacturing & packaging process related to solid oral dosage forms.Develop a compliance plan by...
Grants Development and Compliance Analyst, Bureau of Budget Administration
- Queens Village, NY (20 miles from Huntington, NY)
- 60+ days ago
- Queens Village, NY (20 miles from Huntington, NY)
- 60+ days ago
The Division of Finance has central responsibility and authority for policy analysis, program development, performance tracking and improvement, financial/management, resource maximization and...
Remote Work- Hicksville, NY (9 miles from Huntington, NY)
- 90+ days ago
- Hicksville, NY (9 miles from Huntington, NY)
- 90+ days ago
Position Title Regulatory Affairs Analyst Sr Location Hicksville, NY 11801 Job Summary A Senior Regulatory Relations Analyst, brings regulatory subject matter expertise to the firm and works under...
Demographic Data for Huntington, NY
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Huntington, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Huntington, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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