Regulatory Affairs Specialist Jobs in Elk River, MN
Regulatory Affairs Specialist II
- Boston Scientific
- Maple Grove, MN (14 miles from Elk River, MN)
- 14 days ago
- Maple Grove, MN (14 miles from Elk River, MN)
- 14 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/Sr. Principal Intl Trade Compliance Analyst
- Northrop Grumman
- Plymouth, MN (23 miles from Elk River, MN)
- 15 days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 15 days ago
RELOCATION ASSISTANCE: No relocation assistance available CLEARANCE TYPE: Secret TRAVEL: Yes, 10% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work...
In PersonPrincipal Regulatory Affairs Specialist
- Boston Scientific
- Maple Grove, MN (14 miles from Elk River, MN)
- 16 days ago
- Maple Grove, MN (14 miles from Elk River, 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....
HybridSenior Regulatory Affairs Specialist
- Integer
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ days ago
Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience....
In PersonRegulatory Affairs Specialist II - Interventional Cardiology (Hybrid)
- Boston Scientific
- Maple Grove, MN (14 miles from Elk River, MN)
- 45+ days ago
- Maple Grove, MN (14 miles from Elk River, 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...
HybridRegulatory Affairs Specialist II Electrophysiology (on-site)
- Abbott
- Plymouth, MN (23 miles from Elk River, MN)
- 45+ days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 45+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
In PersonSenior Regulatory Affairs Specialist
- Boston Scientific
- Maple Grove, MN (14 miles from Elk River, MN)
- 60+ days ago
- Maple Grove, MN (14 miles from Elk River, 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 (14 miles from Elk River, MN)
- 90+ days ago
- Maple Grove, MN (14 miles from Elk River, 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 Elk River, MN
Moving to Elk River, MN? Find some basic demographic data about Elk River, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Elk River, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Elk River, 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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