Regulatory Affairs Specialist Jobs in Park City, UT
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
- Murray, UT (20 miles from Park City, UT)
- 6 days ago
- Murray, UT (20 miles from Park City, UT)
- 6 days ago
FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc....
- American Fork, UT (24 miles from Park City, UT)
- 45+ days ago
- American Fork, UT (24 miles from Park City, UT)
- 45+ days ago
COMPANY OVERVIEW Domo's AI and Data Products Platform lets people channel AI and data into innovative uses that deliver a measurable impact. Anyone can use Domo to prepare, analyze, visualize,...
Demographic Data for Park City, UT
Moving to Park City, UT? Find some basic demographic data about Park City, UT below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Park City, UT
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Park City, UT offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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