Regulatory Affairs Specialist Jobs in Somers, 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 - Operations
- Bedford Hills, NY (5 miles from Somers, NY)
- 12 hours ago
- Bedford Hills, NY (5 miles from Somers, NY)
- 12 hours ago
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Compliance Analyst - Core Compliance New Greenwich, CT
- Greenwich, CT (19 miles from Somers, NY)
- 9 days ago
- Greenwich, CT (19 miles from Somers, NY)
- 9 days ago
Compliance Analyst - Core Compliance at Interactive Brokers Greenwich, CT Company Overview Interactive Brokers Group, Inc. (Nasdaq: IBKR) is a global financial services company headquartered in...
- Fairfield, CT (23 miles from Somers, NY)
- 10 days ago
- Fairfield, CT (23 miles from Somers, NY)
- 10 days ago
Job Description: Department: Office of Institutional Research Reports To: Director of Institutional Research Job Status: Full-Time, Exempt Work Mode: Potential hybrid work arrangement (combination...
Compliance Analyst - Core Compliance
- Greenwich, CT (19 miles from Somers, NY)
- 11 days ago
- Greenwich, CT (19 miles from Somers, NY)
- 11 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...
Compliance Analyst, 340B Program ( On-Site )
- Valhalla, NY (16 miles from Somers, NY)
- 12 days ago
- Valhalla, NY (16 miles from Somers, NY)
- 12 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 and Compliance Analyst
- New Canaan, CT (14 miles from Somers, NY)
- 15 days ago
- New Canaan, CT (14 miles from Somers, NY)
- 15 days ago
Job Description: Regulatory and Compliance Analyst is needed to perform the following duties: Coordinate and document Internal Regulatory processes such as Internal Audits, Registrations, License Renewals...
Remote IT Quality Assurance and Compliance, Analyst
- Old Greenwich, CT (20 miles from Somers, NY)
- 17 days ago
- Old Greenwich, CT (20 miles from Somers, NY)
- 17 days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote WorkMarket Data Compliance Analyst
- Greenwich, CT (19 miles from Somers, NY)
- 29 days ago
- Greenwich, CT (19 miles from Somers, NY)
- 29 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...
Compliance Analyst, 340B Program
- Valhalla, NY (16 miles from Somers, NY)
- 60+ days ago
- Valhalla, NY (16 miles from Somers, 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...
- Danbury, CT (12 miles from Somers, NY)
- 60+ days ago
- Danbury, CT (12 miles from Somers, NY)
- 60+ days ago
audits to help ensure compliance with U.S....
Demographic Data for Somers, NY
Moving to Somers, NY? Find some basic demographic data about Somers, NY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Somers, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Somers, 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
- Internal Control
- Management Reporting
- 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
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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