Regulatory Affairs Specialist Jobs in New Haven, 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.
- Trumbull, CT (14 miles from New Haven, CT)
- 1 day ago
- Trumbull, CT (14 miles from New Haven, CT)
- 1 day ago
Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration, or clearance, including filing necessary applications/submissions. Coordinates the...
The Senior Regulatory Affairs Specialist collaborates closely with their team, management, and provides leadership and mentorship to Regulatory Affairs Specialists 1 and 2....
- Stratford, CT (11 miles from New Haven, CT)
- 5 days ago
- Stratford, CT (11 miles from New Haven, CT)
- 5 days ago
Optimus Healthcare- A community health center driven by one mission: to provide high quality, affordable healthcare to the underserved population regardless of their ability to pay. Optimus is the...
- Trumbull, CT (14 miles from New Haven, CT)
- 30+ days ago
- Trumbull, CT (14 miles from New Haven, CT)
- 30+ days ago
Experience with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other international Regulatory requirements (e.g. EU Medical Device Regulations)....
- Trumbull, CT (14 miles from New Haven, CT)
- 45+ days ago
- Trumbull, CT (14 miles from New Haven, CT)
- 45+ days ago
Our client, a leader in the Consumer Packaged Goods industry, is seeking a Regulatory Affairs Specialist to join their team....
Position Focus: Coordinate and conduct research billing reviews for all randomly selected clinical trials with billable services based on risk. Complete risk assessments, billing reviews, assist...
Demographic Data for New Haven, CT
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in New Haven, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in New Haven, CT offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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