Regulatory Affairs Specialist Jobs in Wyoming, 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.
- New Brighton, MN (18 miles from Wyoming, MN)
- 22 days ago
- New Brighton, MN (18 miles from Wyoming, MN)
- 22 days ago
Perform internal audits of origination, post-closing, ad servicing teams to establish and maintain compliance with applicable regulations and investor requirements....
Regulatory Affairs Specialist II
- Maple Grove, MN (24 miles from Wyoming, MN)
- 22 days ago
- Maple Grove, MN (24 miles from Wyoming, MN)
- 22 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....
Regulatory Operations Specialist I
- Little Canada, MN (22 miles from Wyoming, MN)
- 24 days ago
- Little Canada, MN (22 miles from Wyoming, MN)
- 24 days ago
Minnesota > St. Paul > Lillehei : One Lillehei Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous...
Senior Regulatory Affairs Specialist
- Stillwater, MN (22 miles from Wyoming, MN)
- 25 days ago
- Stillwater, MN (22 miles from Wyoming, MN)
- 25 days ago
Submit product and quality system changes to the notified body. Participate in regulatory training and transfer the information back to the Regulatory department providing insightful application....
- Maplewood, MN (22 miles from Wyoming, MN)
- 26 days ago
- Maplewood, MN (22 miles from Wyoming, MN)
- 26 days ago
Job Description: Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life...
Principal Regulatory Affairs Specialist - Electrophysiology
- Arden Hills, MN (18 miles from Wyoming, MN)
- 30+ days ago
- Arden Hills, MN (18 miles from Wyoming, MN)
- 30+ days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Aerospace and Defense Regulatory Affairs Specialist
- Maplewood, MN (22 miles from Wyoming, MN)
- 30+ days ago
- Maplewood, MN (22 miles from Wyoming, MN)
- 30+ days ago
Job Description: Job Title Aerospace and Defense Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your...
Principal Regulatory Affairs Specialist
- Maple Grove, MN (24 miles from Wyoming, MN)
- 30+ days ago
- Maple Grove, MN (24 miles from Wyoming, MN)
- 30+ days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- New Brighton, MN (18 miles from Wyoming, MN)
- 30+ days ago
- New Brighton, MN (18 miles from Wyoming, MN)
- 30+ days ago
Support and comply with the company's Quality Management System policies and procedures. Ability to act with an inclusion mindset and model these behaviors for the organization....
Remote WorkGlobal Respiratory Protection Regulatory Affairs Specialist
- Maplewood, MN (22 miles from Wyoming, MN)
- 60+ days ago
- Maplewood, MN (22 miles from Wyoming, MN)
- 60+ days ago
In this role as Global Respiratory Protection Regulatory Affairs Specialist you will play a key role in advancing occupational health and safety (OHS) culture and practice across 3Ms global markets....
Demographic Data for Wyoming, MN
Moving to Wyoming, MN? Find some basic demographic data about Wyoming, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Wyoming, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Wyoming, 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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