Regulatory Affairs Specialist Jobs in Big Lake, MN
Regulatory Affairs Specialist II
- Boston Scientific
- Maple Grove, MN (22 miles from Big Lake, MN)
- 13 days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 13 days ago
This Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Interventional Cardiology devices, with a primary focus on U.S. and EU compliance activities....
HybridPrincipal Regulatory Affairs Specialist
- Boston Scientific
- Maple Grove, MN (22 miles from Big Lake, MN)
- 16 days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 16 days ago
Prepare, coordinate, and compile regulatory submissions such as PMAs, PMA Supplements, IDEs, 510(k)s, EU MDR Technical Documentation, and pre-submissions....
HybridRegulatory Affairs Specialist II - Interventional Cardiology (Hybrid)
- Boston Scientific
- Maple Grove, MN (22 miles from Big Lake, MN)
- 45+ days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 45+ days ago
As a Regulatory Affairs Specialist II, you will support a broad range of Interventional Cardiology devices, with an emphasis on sustaining commercial products and executing regulatory submissions for...
HybridSenior Regulatory Affairs Specialist
- Boston Scientific
- Maple Grove, MN (22 miles from Big Lake, MN)
- 60+ days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 60+ days ago
The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations...
HybridRegulatory Affairs Specialist - Medical Devices
- Anteris Technologies Global Corp
- Maple Grove, MN (22 miles from Big Lake, MN)
- 90+ days ago
- Maple Grove, MN (22 miles from Big Lake, MN)
- 90+ days ago
Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities for the company's medical device products, with...
In PersonDemographic Data for Big Lake, MN
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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
- Annuities
- 21 CFR 820
- Internal Audits
- Institutional Review Board
- Good Clinical Practice
- ISO 13485
- Document Management
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Continuous Improvement
- Microsoft SharePoint
- Strategy Development
- Reimbursement
- Engineering
- Risk Management
- Analytical Skills
- Auditing
- Implementation
- Written Communication
- Military Background
- Collaboration
- Process Improvement
- Documentation
- Verbal Communication
- Data Analysis
- Investigation
- Reporting
- Education Experience
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Filing
- Project Management
- Research Skills
- Sales
- Regulations
- Microsoft Office
- Time Management
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Teamwork
- Scheduling
- Leadership
- Communication Skills
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