Regulatory Affairs Specialist Jobs in West Point, 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 ( On-Site )
- Valhalla, NY (23 miles from West Point, NY)
- 6 days ago
- Valhalla, NY (23 miles from West Point, NY)
- 6 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...
- Washingtonville, NY (10 miles from West Point, NY)
- 28 days ago
- Washingtonville, NY (10 miles from West Point, NY)
- 28 days ago
The prime responsibility of the position is to provide analytical support and coordination for the NERC CIP Reliability Compliance Program. In addition, the position will serve as a backup to the...
Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
- Mahwah, NJ (24 miles from West Point, NY)
- 30+ days ago
- Mahwah, NJ (24 miles from West Point, NY)
- 30+ days ago
What you will do As the Senior Regulatory Affairs Specialist, you will support Strykers Mako and Enabling Technology portfolio new product development for both US and OUS Global Regulatory release....
Compliance Analyst, 340B Program
- Valhalla, NY (23 miles from West Point, NY)
- 60+ days ago
- Valhalla, NY (23 miles from West Point, NY)
- 60+ 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...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in West Point, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in West Point, 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
- Vendor Management
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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