Regulatory Affairs Specialist Jobs in Middletown, 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 (21 miles from Middletown, CT)
- 3 days ago
- New Haven, CT (21 miles from Middletown, 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...
Product Safety & Regulatory Affairs Specialist
- Rocky Hill, CT (7 miles from Middletown, CT)
- 3 days ago
- Rocky Hill, CT (7 miles from Middletown, CT)
- 3 days 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...
Senior Regulatory Affairs Specialist
- New Haven, CT (21 miles from Middletown, CT)
- 6 days ago
- New Haven, CT (21 miles from Middletown, 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....
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Hartford, CT (16 miles from Middletown, CT)
- 14 days ago
- Hartford, CT (16 miles from Middletown, CT)
- 14 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote Work- West Hartford, CT (15 miles from Middletown, CT)
- 23 days ago
- West Hartford, CT (15 miles from Middletown, CT)
- 23 days ago
Comply with any specific responsibilities necessary for your role as outlined by your line manager, talent management or assurance teams (compliance, risk, internal audit) and ensure you keep up to...
Demographic Data for Middletown, CT
Moving to Middletown, CT? Find some basic demographic data about Middletown, CT below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Middletown, CT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Middletown, 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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