Regulatory Affairs Specialist Jobs in Valhalla, 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.
Market Data Compliance Analyst
- Greenwich, CT (8 miles from Valhalla, NY)
- 2 days ago
- Greenwich, CT (8 miles from Valhalla, NY)
- 2 days ago
Company Overview Interactive Brokers Group, Inc. (Nasdaq: IBKR) is a global financial services company headquartered in Greenwich, CT, USA, with offices in over 15 countries. We have been at the...
R&D Regulatory Affairs Associate Principal Scientist
- Valhalla, NY
- 15 days ago
- Valhalla, NY
- 15 days ago
Overview PepsiCo is a global food and beverage leader operating in more than 200 countries and territories with a product portfolio that includes 22 world-famous, billion-dollar brands. From...
Quality Assurance and Regulatory Affairs Specialist
- Bogota, NJ (19 miles from Valhalla, NY)
- 16 days ago
- Bogota, NJ (19 miles from Valhalla, NY)
- 16 days ago
Quality Assurance and Regulatory Affairs Specialist Description The Quality Assurance and Regulatory Affairs Specialist will be responsible for supporting local Quality and Regulatory strategies, including...
Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
- Mahwah, NJ (20 miles from Valhalla, NY)
- 16 days ago
- Mahwah, NJ (20 miles from Valhalla, NY)
- 16 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....
M/WBE Outreach & Compliance Analyst
- Queens Village, NY (24 miles from Valhalla, NY)
- 30+ days ago
- Queens Village, NY (24 miles from Valhalla, NY)
- 30+ days ago
Hours: Full-Time - 35 Hours Work Location: 30-30 Thomson Avenue, NY, 11101 The NYC Department of Design and Construction, Office of Diversity, and Industry Relations (ODIR) seeks a Minority and...
- Hasbrouck Heights, NJ (21 miles from Valhalla, NY)
- 30+ days ago
- Hasbrouck Heights, NJ (21 miles from Valhalla, NY)
- 30+ days ago
audit and regulatory examination requests, engage with business units to address findings and help prepare responses....
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...
Grants Development and Compliance Analyst, Bureau of Budget Administration
- Queens Village, NY (24 miles from Valhalla, NY)
- 90+ days ago
- Queens Village, NY (24 miles from Valhalla, NY)
- 90+ 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...
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Valhalla, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Valhalla, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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