Regulatory Affairs Specialist Jobs in Washingtonville, 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.
Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
- Mahwah, NJ (24 miles from Washingtonville, NY)
- 9 hours ago
- Mahwah, NJ (24 miles from Washingtonville, NY)
- 9 hours ago
Work Flexibility: Hybrid We are currently seeking a Staff Regulatory Affairs Specialist to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid in...
Technology Quality & Compliance Analyst
- Poughkeepsie, NY (22 miles from Washingtonville, NY)
- 4 days ago
- Poughkeepsie, NY (22 miles from Washingtonville, NY)
- 4 days ago
Benefits : Competitive compensation Medical, dental, and vision insurance 401(k) retirement savings plan with substantial company match Life and travel insurance Tuition assistance Wellness...
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...
- Middletown, NY (16 miles from Washingtonville, NY)
- 60+ days ago
- Middletown, NY (16 miles from Washingtonville, NY)
- 60+ days ago
Apply Job Type Full-time Description Join a Purpose-Driven Team at Heritage Financial Credit Union Where Integrity, Excellence, Teamwork, and Community Matter! Heritage Financial Credit Union is a...
Demographic Data for Washingtonville, NY
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Washingtonville, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Washingtonville, 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
- Internal Control
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Written Communication
- Education Experience
- Documentation
- Investigation
- Verbal Communication
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Project Management
- Problem Solving
- Regulations
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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