Regulatory Affairs Specialist Jobs in Skaneateles Falls, 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.
Regulatory Affairs Specialist-Principal
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 2 days ago
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 2 days ago
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel...
Legal & Compliance Analyst - $22.00/hour
- Waterloo, NY (22 miles from Skaneateles Falls, NY)
- 4 days ago
- Waterloo, NY (22 miles from Skaneateles Falls, NY)
- 4 days ago
POSITION SUMMARY Position is responsible for administration and analysis of the regulatory compliance, and legal affairs programs, as well as, other administrative tasks as assigned by VP Legal...
USA - Regulatory Affairs Associate III
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 24 days ago
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 24 days ago
USA - Regulatory Affairs Associate III#25-54522 $51.45-$53.45 per hour Skaneateles, NY All On-site Job Description Can be fully remote or hybrid Under general supervision responsible for the...
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 30+ days ago
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 30+ days ago
Regulatory Affairs Associate Job Description Job Title: Regulatory Affairs Associate Location: Skaneateles, NY 13153- Can be fully remote or hybrid Duration: 12 Months Description: Under general...
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Regulatory Affairs Associate III
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 30+ days ago
- Skaneateles, NY (8 miles from Skaneateles Falls, NY)
- 30+ days ago
Pay Range : $ 40/hr to $ 63/Hr (Depending on Experience & Skills) Can be fully remote or hybrid Under general supervision responsible for the coordination and the preparation of documents/packages...
Remote WorkRegulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Skaneateles Falls, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Skaneateles Falls, 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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