Regulatory Affairs Specialist Jobs in Milford, 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 (9 miles from Milford, CT)
- 3 days ago
- New Haven, CT (9 miles from Milford, CT)
- 3 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...
- Trumbull, CT (8 miles from Milford, CT)
- 5 days ago
- Trumbull, CT (8 miles from Milford, CT)
- 5 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 (9 miles from Milford, CT)
- 6 days ago
- New Haven, CT (9 miles from Milford, CT)
- 6 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 (4 miles from Milford, CT)
- 8 days ago
- Stratford, CT (4 miles from Milford, CT)
- 8 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 (8 miles from Milford, CT)
- 30+ days ago
- Trumbull, CT (8 miles from Milford, 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)....
Demographic Data for Milford, CT
Moving to Milford, CT? Find some basic demographic data about Milford, CT below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Milford, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Milford, 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
- Institutional Review Board
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Lean Six Sigma
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- 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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