Regulatory Affairs Specialist Jobs in Buffalo, 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 (12 miles from Buffalo, MN)
- 18 days ago
- Rogers, MN (12 miles from Buffalo, MN)
- 18 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 (17 miles from Buffalo, MN)
- 45+ days ago
- Maple Grove, MN (17 miles from Buffalo, MN)
- 45+ 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....
Sr. Business System Compliance Analyst
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Senior Regulatory Affairs Specialist (on-site)
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN....
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Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (23 miles from Buffalo, MN)
- 45+ days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 45+ days ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL...
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 60+ days ago
The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....
Demographic Data for Buffalo, MN
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Buffalo, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Buffalo, 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
- Internal Control
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- 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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