Regulatory Affairs Specialist Jobs in Big Lake, MN
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.
Regulatory Compliance Specialist
- Rogers, MN (18 miles from Big Lake, MN)
- 6 days ago
- Rogers, MN (18 miles from Big Lake, MN)
- 6 days ago
North Star Imaging (NSI), a global leader in 2D digital radiography and 3D computed tomography equipment, is part of Illinois Tool Works (ITW), a Fortune 250 company. We offer an engaging work...
Regulatory Affairs Specialist II
- Maple Grove, MN (22 miles from Big Lake, MN)
- 30+ days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 30+ days ago
This Regulatory Affairs Specialist II role will provide regulatory support on a wide variety of Interventional Cardiology devices with a focus on supporting US and EU compliance activities....
Principal Regulatory Affairs Specialist
- Maple Grove, MN (22 miles from Big Lake, MN)
- 45+ days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 45+ days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Demographic Data for Big Lake, MN
Moving to Big Lake, MN? Find some basic demographic data about Big Lake, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Big Lake, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Big Lake, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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