Regulatory Affairs Specialist Jobs in Melville, 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.
Sr. Regulatory Compliance Specialist
- Farmingdale, NY (3 miles from Melville, NY)
- 1 day ago
- Farmingdale, NY (3 miles from Melville, NY)
- 1 day 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...
Market Data Compliance Analyst
- Greenwich, CT (21 miles from Melville, NY)
- 3 days ago
- Greenwich, CT (21 miles from Melville, NY)
- 3 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...
Regulatory Affairs Coordinator
- Plainview, NY (3 miles from Melville, NY)
- 28 days ago
- Plainview, NY (3 miles from Melville, NY)
- 28 days ago
Overview Under the direction of the Vice President of Quality Improvement and Compliance, the Regulatory Affairs Coordinator is responsible for ensuring that programs, services, and operations...
M/WBE Outreach & Compliance Analyst
- Queens Village, NY (18 miles from Melville, NY)
- 30+ days ago
- Queens Village, NY (18 miles from Melville, 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...
Grants Development and Compliance Analyst, Bureau of Budget Administration
- Queens Village, NY (18 miles from Melville, NY)
- 90+ days ago
- Queens Village, NY (18 miles from Melville, 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 Melville, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Melville, 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
- Interpersonal Skills
- 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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