Regulatory Affairs Specialist Jobs in Dacono, 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.
- Lafayette, CO (8 miles from Dacono, CO)
- 1 hour ago
- Lafayette, CO (8 miles from Dacono, CO)
- 1 hour ago
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections....
Principal Reg Affairs Specialist
- Lafayette, CO (8 miles from Dacono, CO)
- 3 days ago
- Lafayette, CO (8 miles from Dacono, CO)
- 3 days ago
A Day in the Life Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global...
Compliance Analyst- Environmental compliance
- Loveland, CO (23 miles from Dacono, CO)
- 7 days ago
- Loveland, CO (23 miles from Dacono, CO)
- 7 days ago
Compliance Analyst- Environmental compliance Job ID: 447561 Posted 1 day ago loveland, Colorado Contract to Hire All Other $25-35 Job Details IDR is seeking a Compliance Analyst- Environmental...
Regulatory Affairs Specialist - ACM
- Lafayette, CO (8 miles from Dacono, CO)
- 30+ days ago
- Lafayette, CO (8 miles from Dacono, CO)
- 30+ days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
- Boulder, CO (13 miles from Dacono, CO)
- 30+ days ago
- Boulder, CO (13 miles from Dacono, CO)
- 30+ days ago
About The Role The Regulatory Affairs Specialist supports our product teams supporting new product development and lifecycle management....
Demographic Data for Dacono, CO
Moving to Dacono, CO? Find some basic demographic data about Dacono, CO below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Dacono, CO
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Dacono, CO offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Written Communication
- Education Experience
- Investigation
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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