Regulatory Affairs Specialist Jobs in Boulder, CO
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.
Senior Regulatory Affairs Specialist
- Lafayette, CO (5 miles from Boulder, CO)
- 5 days ago
- Lafayette, CO (5 miles from Boulder, CO)
- 5 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Knowledge of FDA regulations, international guidelines, and the ability to advise on fast-track analysis, pediatric studies, and emergency inquiries....
- Arvada, CO (18 miles from Boulder, CO)
- 22 days ago
- Arvada, CO (18 miles from Boulder, CO)
- 22 days ago
Location: UCHealth UCHlth Admin 2450 Peoria, US:CO:Aurora Department: UCHlth Compliance FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $36.19 - $54.28 / hour. Pay is...
- Broomfield, CO (11 miles from Boulder, CO)
- 45+ days ago
- Broomfield, CO (11 miles from Boulder, CO)
- 45+ days ago
What it's about The Marketing Compliance Analyst will be part of a global team that reviews all marketing presentations promoting the firm's services and products. The position will involve...
Senior Security Risk and Compliance Analyst
- Louisville, CO (6 miles from Boulder, CO)
- 45+ days ago
- Louisville, CO (6 miles from Boulder, CO)
- 45+ days ago
Elastic, the Search AI Company, enables everyone to find the answers they need in real time, using all their data, at scale unleashing the potential of businesses and people. The Elastic Search AI...
Remote WorkDo you want to be part of a business that genuinely values entrepreneurialism, innovation and individual accountability? We focus on our customers and are proud of the difference our technology...
Demographic Data for Boulder, CO
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Boulder, CO
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Boulder, CO 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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