Regulatory Affairs Specialist Jobs in North 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.
IT Governance, Risk, and Compliance Analyst
- New Haven, CT (6 miles from North Haven, CT)
- 8 hours ago
- New Haven, CT (6 miles from North Haven, CT)
- 8 hours ago
The individual should have work experience totaling 7+ years for both role types, which will enable them to work with ITS leadership and Internal Audit to develop, maintain, and improve the IT controls...
Product Safety & Regulatory Affairs Specialist
- Rocky Hill, CT (21 miles from North Haven, CT)
- 16 hours ago
- Rocky Hill, CT (21 miles from North Haven, CT)
- 16 hours ago
About this Position At Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging...
- Trumbull, CT (19 miles from North Haven, CT)
- 2 days ago
- Trumbull, CT (19 miles from North Haven, CT)
- 2 days ago
Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration, or clearance, including filing necessary applications/submissions. Coordinates the...
Senior Regulatory Affairs Specialist
- New Haven, CT (6 miles from North Haven, CT)
- 3 days ago
- New Haven, CT (6 miles from North Haven, CT)
- 3 days ago
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 (17 miles from North Haven, CT)
- 5 days ago
- Stratford, CT (17 miles from North 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 (19 miles from North Haven, CT)
- 30+ days ago
- Trumbull, CT (19 miles from North 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)....
Anti-Bribery & Anti-Corruption Compliance Analyst
- New Britain, CT (19 miles from North Haven, CT)
- 30+ days ago
- New Britain, CT (19 miles from North Haven, CT)
- 30+ days ago
In this high-impact role, youll work with key stakeholders across Legal, Internal Audit, and Finance to design and implement cutting-edge compliance controls that ensure we meet global anti-bribery...
- Trumbull, CT (19 miles from North Haven, CT)
- 45+ days ago
- Trumbull, CT (19 miles from North 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....
YCCI Research Billing Compliance Analyst
- New Haven, CT (6 miles from North Haven, CT)
- 90+ days ago
- New Haven, CT (6 miles from North Haven, CT)
- 90+ days ago
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 North Haven, CT
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in North Haven, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in North 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
- Analytical Skills
- 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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