Regulatory Affairs Specialist Jobs in Pleasantville, 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 - Core Compliance New Greenwich, CT
- Greenwich, CT (10 miles from Pleasantville, NY)
- 22 hours ago
- Greenwich, CT (10 miles from Pleasantville, NY)
- 22 hours 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...
Quality Assurance and Regulatory Affairs Specialist
- Bogota, NJ (21 miles from Pleasantville, NY)
- 1 day ago
- Bogota, NJ (21 miles from Pleasantville, NY)
- 1 day 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...
Compliance Analyst - Core Compliance
- Greenwich, CT (10 miles from Pleasantville, NY)
- 2 days ago
- Greenwich, CT (10 miles from Pleasantville, 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...
Compliance Analyst, 340B Program ( On-Site )
- Valhalla, NY (2 miles from Pleasantville, NY)
- 3 days ago
- Valhalla, NY (2 miles from Pleasantville, NY)
- 3 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...
- Stamford, CT (14 miles from Pleasantville, NY)
- 6 days ago
- Stamford, CT (14 miles from Pleasantville, NY)
- 6 days ago
Position Summary Do you have a nose for recognizing and managing risk as an organization takes on new business and projects? Is one of your strengths investigating and researching to find...
Regulatory and Compliance Analyst
- New Canaan, CT (15 miles from Pleasantville, NY)
- 6 days ago
- New Canaan, CT (15 miles from Pleasantville, NY)
- 6 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 (13 miles from Pleasantville, NY)
- 8 days ago
- Old Greenwich, CT (13 miles from Pleasantville, NY)
- 8 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 WorkRegulatory Affairs Associate Director
- Franklin Lakes, NJ (23 miles from Pleasantville, NY)
- 12 days ago
- Franklin Lakes, NJ (23 miles from Pleasantville, NY)
- 12 days ago
Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations....
Market Data Compliance Analyst
- Greenwich, CT (10 miles from Pleasantville, NY)
- 20 days ago
- Greenwich, CT (10 miles from Pleasantville, NY)
- 20 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...
Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
- Mahwah, NJ (20 miles from Pleasantville, NY)
- 30+ days ago
- Mahwah, NJ (20 miles from Pleasantville, 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....
- Hasbrouck Heights, NJ (23 miles from Pleasantville, NY)
- 60+ days ago
- Hasbrouck Heights, NJ (23 miles from Pleasantville, NY)
- 60+ days ago
audit and regulatory examination requests, engage with business units to address findings and help prepare responses....
Compliance Analyst, 340B Program
- Valhalla, NY (2 miles from Pleasantville, NY)
- 60+ days ago
- Valhalla, NY (2 miles from Pleasantville, 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 (24 miles from Pleasantville, NY)
- 60+ days ago
- Danbury, CT (24 miles from Pleasantville, NY)
- 60+ days ago
audits to help ensure compliance with U.S....
Demographic Data for Pleasantville, NY
Moving to Pleasantville, NY? Find some basic demographic data about Pleasantville, NY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pleasantville, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pleasantville, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Writing Skills
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »