Regulatory Affairs Specialist Jobs in Louisville, 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.
Compliance Analyst, Fidelity Digital Asset Services Compliance
- Greenwood Village, CO (22 miles from Louisville, CO)
- 2 days ago
- Greenwood Village, CO (22 miles from Louisville, CO)
- 2 days ago
Compliance Analyst, Fidelity Digital Asset Services Compliance Fidelity Investments - 4.0 Greenwood Village, CO Job Details $58,000 - $91,000 a year 20 hours ago Benefits Loan repayment program...
Regulatory Affairs Specialist II
- Denver, CO (24 miles from Louisville, CO)
- 3 days ago
- Denver, CO (24 miles from Louisville, CO)
- 3 days ago
FDA, Health Canada), as well as regulatory assessments and reviews of quality management system documents....
Senior Regulatory Affairs Specialist - ACM
- Lafayette, CO (5 miles from Louisville, CO)
- 6 days ago
- Lafayette, CO (5 miles from Louisville, CO)
- 6 days ago
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
- Denver, CO (24 miles from Louisville, CO)
- 8 days ago
- Denver, CO (24 miles from Louisville, CO)
- 8 days ago
, a division of UMB Bank n.a. Are you ready to be part of something more? You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people...
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Principal Regulatory Affairs Specialist (SaMD)
- Denver, CO (24 miles from Louisville, CO)
- 10 days ago
- Denver, CO (24 miles from Louisville, CO)
- 10 days ago
Principal Regulatory Affairs Specialist (SaMD) Principal Regulatory Affairs Specialist (SaMD) Denver, Colorado, United States About Cleerly We're Cleerly - a healthcare company that's revolutionizing...
Senior Principal Regulatory Affairs Specialist - Robotic Surgical Technologies
- Lafayette, CO (5 miles from Louisville, CO)
- 12 days ago
- Lafayette, CO (5 miles from Louisville, CO)
- 12 days ago
A Day in the Life The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets....
Principal Regulatory Affairs Specialist (SaMD)
- Denver, CO (24 miles from Louisville, CO)
- 13 days ago
- Denver, CO (24 miles from Louisville, CO)
- 13 days ago
Expertise: Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices....
Lead Compliance Analyst (Broker-Dealer, Investment Advisor, Insurance Agency)
- Denver, CO (24 miles from Louisville, CO)
- 13 days ago
- Denver, CO (24 miles from Louisville, CO)
- 13 days ago
These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications...
- Denver, CO (24 miles from Louisville, CO)
- 15 days ago
- Denver, CO (24 miles from Louisville, CO)
- 15 days ago
Utilities Compliance Analyst 3.6 3.6 out of 5 stars Denver, CO System One is actively recruiting for a Utilities Compliance Analyst for a long-term contract position located in Denver. Utilities...
- Denver, CO (24 miles from Louisville, CO)
- 17 days ago
- Denver, CO (24 miles from Louisville, CO)
- 17 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote Work- Denver, CO (24 miles from Louisville, CO)
- 20 days ago
- Denver, CO (24 miles from Louisville, CO)
- 20 days ago
What will you do? A day in the life of a Customs Compliance Analyst at VF looks a little like this. The Customs Compliance Analyst is to provide support in customs compliance for the VF Outdoor...
- Denver, CO (24 miles from Louisville, CO)
- 21 days ago
- Denver, CO (24 miles from Louisville, CO)
- 21 days ago
Job Description: The compliance analyst assists in oversight of the compliance program and security controls for the organization. Responsibilities include assisting with managing the controls,...
- Arvada, CO (11 miles from Louisville, CO)
- 22 days ago
- Arvada, CO (11 miles from Louisville, CO)
- 22 days ago
Location: UCHealth UCHlth Memorial Admin Ctr, US:CO:Colorado Springs; This position can sit in either Colorado Springs or the Denver/Metro area. Candidate must reside in Colorado. Department:...
- Denver, CO (24 miles from Louisville, CO)
- 27 days ago
- Denver, CO (24 miles from Louisville, CO)
- 27 days ago
POSITION DESCRIPTION Position Title: Compliance Analyst Reports To: Manager, NERC Compliance Direct Reports:
Senior Auditing & Compliance Analyst
- Denver, CO (24 miles from Louisville, CO)
- 28 days ago
- Denver, CO (24 miles from Louisville, CO)
- 28 days ago
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Demographic Data for Louisville, CO
Moving to Louisville, CO? Find some basic demographic data about Louisville, CO below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Louisville, CO
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Louisville, 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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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