Regulatory Affairs Specialist Jobs in East 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.
Environmental Regulatory Compliance Specialist
- Guilford, CT (9 miles from East Haven, CT)
- 25 days ago
- Guilford, CT (9 miles from East Haven, CT)
- 25 days ago
Triton Environmental, a part of True Environmental and its partner firms, have united their strengths to establish the nation's premier environmental and engineering services consulting firm. This...
- Trumbull, CT (17 miles from East Haven, CT)
- 60+ days ago
- Trumbull, CT (17 miles from East Haven, CT)
- 60+ 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)....
IT Governance, Risk, and Compliance Analyst
- New Haven, CT (3 miles from East Haven, CT)
- 30+ days ago
- New Haven, CT (3 miles from East Haven, CT)
- 30+ days 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...
- Stratford, CT (13 miles from East Haven, CT)
- 30+ days ago
- Stratford, CT (13 miles from East Haven, CT)
- 30+ 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...
Demographic Data for East Haven, CT
Moving to East Haven, CT? Find some basic demographic data about East Haven, CT below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in East Haven, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in East 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
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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