Regulatory Affairs Specialist Jobs in Guilford, CT
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.
- Yale University
- New Haven, CT (12 miles from Guilford, CT)
- 13 days ago
- New Haven, CT (12 miles from Guilford, CT)
- 13 days ago
Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for complex clinical research studies....
In Person- Medtronic
- North Haven, CT (9 miles from Guilford, CT)
- 14 days ago
- North Haven, CT (9 miles from Guilford, CT)
- 14 days ago
A Day in the Life The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio....
In Person- System One
- Rocky Hill, CT (21 miles from Guilford, CT)
- 28 days ago
- Rocky Hill, CT (21 miles from Guilford, CT)
- 28 days ago
Job Title : Regulatory Affairs Specialist Location : Rocky Hill, CT Contractor Work Model : Onsite Hours : M F 8am 5pm Compensation : $26.00/hr Type : Contract, Potential for extension or conversion...
In Person- LGC Ltd
- Milford, CT (20 miles from Guilford, CT)
- 45+ days ago
- Milford, CT (20 miles from Guilford, CT)
- 45+ days ago
Job Description We're looking for a meticulous and analytical Regulatory Affairs Specialist to join our team in Milford, United States....
In PersonSenior Regulatory Affairs Specialist
- Hyperfine Inc
- Guilford, CT
- 45+ days ago
- Guilford, CT
- 45+ days ago
Learn More About The Role Job Title: Senior Regulatory Affairs Specialist Location: Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week) The Senior Regulatory Affairs Specialist advises regulatory strategy...
HybridDemographic Data for Guilford, CT
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Guilford, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Guilford, CT offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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