Regulatory Affairs Specialist Jobs in Durham, 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.
Trade Compliance Analyst Remote
- New Britain, CT (14 miles from Durham, CT)
- 23 days ago
- New Britain, CT (14 miles from Durham, CT)
- 23 days ago
East Coast or hybrid to New Britain, CT Come make the world and accelerate your success. It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a...
Remote WorkOperational Compliance Analyst
- New Haven, CT (16 miles from Durham, CT)
- 30+ days ago
- New Haven, CT (16 miles from Durham, CT)
- 30+ days ago
Feel Good About Doing Good The Knights of Columbus is a tax-exempt Catholic fraternal benefit society that provides financial security to members and their families through our life insurance,...
Regulatory Affairs Specialist - Post Market
- Hartford, CT (22 miles from Durham, CT)
- 30+ days ago
- Hartford, CT (22 miles from Durham, CT)
- 30+ days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkOperational Compliance Analyst
- New Haven, CT (16 miles from Durham, CT)
- 30+ days ago
- New Haven, CT (16 miles from Durham, CT)
- 30+ days ago
Feel Good About Doing Good The Knights of Columbus is a tax-exempt Catholic fraternal benefit society that provides financial security to members and their families through our life insurance,...
Environmental Regulatory Compliance Specialist
- Guilford, CT (8 miles from Durham, CT)
- 90+ days ago
- Guilford, CT (8 miles from Durham, CT)
- 90+ 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...
Demographic Data for Durham, CT
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Durham, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Durham, 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
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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