Regulatory Affairs Specialist Jobs in Hillburn, 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.
- Washingtonville, NY (21 miles from Hillburn, NY)
- 9 days ago
- Washingtonville, NY (21 miles from Hillburn, NY)
- 9 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...
- Parsippany, NJ (22 miles from Hillburn, NY)
- 14 days ago
- Parsippany, NJ (22 miles from Hillburn, NY)
- 14 days ago
Trade Compliance AnalystPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating through its subsidiaries, oil refineries and related facilities. We are...
R&D Regulatory Affairs Associate Principal Scientist
- Valhalla, NY (20 miles from Hillburn, NY)
- 17 days ago
- Valhalla, NY (20 miles from Hillburn, NY)
- 17 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 (18 miles from Hillburn, NY)
- 17 days ago
- Bogota, NJ (18 miles from Hillburn, NY)
- 17 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 (3 miles from Hillburn, NY)
- 18 days ago
- Mahwah, NJ (3 miles from Hillburn, NY)
- 18 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....
- Fairfield, NJ (18 miles from Hillburn, NY)
- 18 days ago
- Fairfield, NJ (18 miles from Hillburn, NY)
- 18 days ago
Company Description We are SGS the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600...
Regional FSTDO Standards & Regulatory Compliance Specialist
- Whippany, NJ (24 miles from Hillburn, NY)
- 26 days ago
- Whippany, NJ (24 miles from Hillburn, NY)
- 26 days ago
About This Role Support the FSTDO Standards & Compliance Manager in work related to ensuring FSTDO standards and regulatory compliance for the assigned region, responsibilities include but not...
- Parsippany, NJ (22 miles from Hillburn, NY)
- 30+ days ago
- Parsippany, NJ (22 miles from Hillburn, NY)
- 30+ days ago
About Blue Foundry Bank This is the Bank Where Things are Made. Blue Foundry is a bank where businesses are shaped, plans are formed, ideas are refined, solutions are built, and stuff gets done....
- Hasbrouck Heights, NJ (18 miles from Hillburn, NY)
- 30+ days ago
- Hasbrouck Heights, NJ (18 miles from Hillburn, NY)
- 30+ days ago
audit and regulatory examination requests, engage with business units to address findings and help prepare responses....
Sustainability Specialist - Tariff & Supply Chain Compliance Analyst
- Lyndhurst, NJ (23 miles from Hillburn, NY)
- 45+ days ago
- Lyndhurst, NJ (23 miles from Hillburn, NY)
- 45+ days ago
Job Description: Inquire for details Job Requirements: Bachelor's degree required; Inquire for details Job Criteria: Start Date: 10/01/2025 Position Type: Full-Time Temporary Years of Experience...
Compliance Analyst, 340B Program
- Valhalla, NY (20 miles from Hillburn, NY)
- 45+ days ago
- Valhalla, NY (20 miles from Hillburn, NY)
- 45+ 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...
Demographic Data for Hillburn, NY
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hillburn, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hillburn, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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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