Regulatory Affairs Specialist Jobs in Lakeville, 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 Affairs Specialist II - Ventures (on-site)
- Saint Paul, MN (24 miles from Lakeville, MN)
- 45+ days ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 45+ days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Governance, Risk and Compliance Analyst - ITS3
- Saint Paul, MN (24 miles from Lakeville, MN)
- 1 day ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 1 day ago
Working Title: Governance, Risk and Compliance Analyst** **Job Class: Information Technology Specialist 3** **Agency: Minnesota IT Services** + **Job ID** : 87324 + **Location** : St. Paul +...
Compliance Analyst - Policy Management and Testing
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day 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 Product Compliance Analyst
- Chaska, MN (20 miles from Lakeville, MN)
- 2 days ago
- Chaska, MN (20 miles from Lakeville, MN)
- 2 days ago
Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with...
- Minneapolis, MN (24 miles from Lakeville, MN)
- 4 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 4 days ago
We have an exciting opportunity as a Sr. Compliance Analyst to join the team at Ameriprise! In this role you will assist in ensuring communications satisfy regulatory and corporate requirements;...
Sr Payroll Tax and Compliance Analyst
- Golden Valley, MN (21 miles from Lakeville, MN)
- 9 days ago
- Golden Valley, MN (21 miles from Lakeville, MN)
- 9 days ago
Job Duties: Ensure accurate and timely processing of monthly, quarterly, and annual multistate payroll tax filings and payments in compliance with federal, state, and local regulations. Including...
- Minneapolis, MN (24 miles from Lakeville, MN)
- 11 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 11 days 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....
Cloud Security Risk and Compliance Analyst
- Minneapolis, MN (24 miles from Lakeville, MN)
- 13 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 13 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 Regulatory Affairs Specialist
- Chaska, MN (20 miles from Lakeville, MN)
- 15 days ago
- Chaska, MN (20 miles from Lakeville, MN)
- 15 days ago
Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN....
Document Control Records Management - Regulatory Affairs Specialist - Senior
- Chaska, MN (20 miles from Lakeville, MN)
- 16 days ago
- Chaska, MN (20 miles from Lakeville, MN)
- 16 days ago
Regulatory Affairs Specialist - Senior Job Description: 3 must haves - 1) Experience with design changes, 2) demonstrated RA leadership on high visibility core team, 3) IVDR or EMDR experience The Senior...
Sr Digital Security & Compliance Analyst
- Minneapolis, MN (24 miles from Lakeville, MN)
- 23 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 23 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...
Regulatory Affairs Associate (#956) - Minneapolis
- Minneapolis, MN (24 miles from Lakeville, MN)
- 27 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 27 days ago
Regulatory Affairs Associate (#956) - Minneapolis Dorsey & Whitney LLP - 3.8 Minneapolis, MN Job Details $210,000 - $265,000 a year 17 hours ago Benefits Travel reimbursement Paid parental leave...
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology...
Compliance Analyst/ Compliance Analyst Senior Hybrid
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
He/She will also support direct regulatory requests, market conduct exams and internal audit requests....
REMOTE Part Time Sr Regulatory Affairs Specialist
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
Close REMOTE Part Time Sr Regulatory Affairs Specialist Minneapolis, Minnesota Mechanical Engineering 258 days ago Apply Job Summary: Responsible for managing regulatory compliance for product modifications...
Remote WorkDemographic Data for Lakeville, MN
Moving to Lakeville, MN? Find some basic demographic data about Lakeville, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lakeville, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lakeville, 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
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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