Regulatory Affairs Specialist Jobs in Saint Michael, 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.
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 10 hours ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 10 hours ago
Regulatory Affairs Specialist responsible for reviewing and assessing changes to Class II medical devices, supporting global regulatory compliance, and collaborating with cross-functional teams....
Regulatory Affairs Specialist II
- Maple Grove, MN (9 miles from Saint Michael, MN)
- 10 hours ago
- Maple Grove, MN (9 miles from Saint Michael, MN)
- 10 hours ago
Participate in development and implementation of departmental policies and procedures Foster a work environment of continuous improvement that supports BSCs Quality Policy, Quality System and the appropriate...
Environmental Compliance Analyst
- Fridley, MN (22 miles from Saint Michael, MN)
- 2 days ago
- Fridley, MN (22 miles from Saint Michael, MN)
- 2 days ago
Atlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in...
Cloud Security Risk and Compliance Analyst
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 2 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 2 days ago
At U.S. Bank, were on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and...
Senior Information Security Risk & Compliance Analyst/Consultant Actions
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 3 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 3 days ago
At U.S. Bank, were on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and...
Compliance Analyst (R25_0000002183)
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 4 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 4 days ago
We are searching for a Compliance Analyst within the General Counsel's Organization team, who is a hardworking self-starter motivated by achieving and exceeding goals who will support the...
Revenue Cycle Senior Compliance Analyst - Remote
- Eden Prairie, MN (23 miles from Saint Michael, MN)
- 5 days ago
- Eden Prairie, MN (23 miles from Saint Michael, MN)
- 5 days ago
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by...
Remote Work- Minneapolis, MN (24 miles from Saint Michael, MN)
- 5 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 5 days ago
The Regulatory Affairs Specialist is full-time, on-site role based in a Kerecis office....
Principal Regulatory Affairs Specialist
- Plymouth, MN (17 miles from Saint Michael, MN)
- 5 days ago
- Plymouth, MN (17 miles from Saint Michael, MN)
- 5 days ago
You have expertise in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations....
Regulatory Affairs Specialist - Medical Devices
- Maple Grove, MN (9 miles from Saint Michael, MN)
- 5 days ago
- Maple Grove, MN (9 miles from Saint Michael, MN)
- 5 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...
- Mounds View, MN (24 miles from Saint Michael, MN)
- 5 days ago
- Mounds View, MN (24 miles from Saint Michael, MN)
- 5 days ago
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections....
Sr Prncpl Intl Trade Compliance Analyst
- Plymouth, MN (17 miles from Saint Michael, MN)
- 6 days ago
- Plymouth, MN (17 miles from Saint Michael, MN)
- 6 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...
Principal Regulatory Affairs Specialist
- Mounds View, MN (24 miles from Saint Michael, MN)
- 6 days ago
- Mounds View, MN (24 miles from Saint Michael, MN)
- 6 days ago
A Day in the Life As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies....
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 8 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 8 days ago
Overview The Compliance Analyst is responsible for supporting the development, implementation and execution of the company's corporate compliance and privacy programs. This individual will support...
Sr Digital Security & Compliance Analyst
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 12 days ago
- Minneapolis, MN (24 miles from Saint Michael, MN)
- 12 days ago
Sr Digital Security & Compliance Analyst Job ID 217637 Posted 19-May-2025 Service line Advisory Segment Role type Full-time Areas of Interest Accounting/Finance, Digital & Technology/Information...
Demographic Data for Saint Michael, MN
Moving to Saint Michael, MN? Find some basic demographic data about Saint Michael, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Saint Michael, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Saint Michael, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Consulting
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Data Entry
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Multitasking
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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