Regulatory Affairs Specialist Jobs in Maple Grove, 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 (14 miles from Maple Grove, MN)
- 1 day ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 1 day ago
, a division of UMB Bank n.a. Are you ready to be part of something more? You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people...
Regulatory Affairs Analyst - Nationwide Remote
- Minnetonka, MN (12 miles from Maple Grove, MN)
- 2 days ago
- Minnetonka, MN (12 miles from Maple Grove, MN)
- 2 days ago
Regulatory Affairs Analyst - Nationwide Remote (part of UnitedHealth Group) 3.7 3.7 out of 5 stars Minnetonka, MN 55305 Remote At UnitedHealthcare, we're simplifying the health care experience,...
Remote WorkPrincipal Regulatory Affairs Specialist - Electrophysiology
- Arden Hills, MN (15 miles from Maple Grove, MN)
- 3 days ago
- Arden Hills, MN (15 miles from Maple Grove, MN)
- 3 days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Senior Principal Regulatory Affairs Specialist - Robotic Surgical Technologies
- Mounds View, MN (15 miles from Maple Grove, MN)
- 5 days ago
- Mounds View, MN (15 miles from Maple Grove, MN)
- 5 days ago
A Day in the Life The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets....
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Regulatory Affairs Specialist I
- Little Canada, MN (18 miles from Maple Grove, MN)
- 6 days ago
- Little Canada, MN (18 miles from Maple Grove, MN)
- 6 days ago
Minnesota > St. Paul > Lillehei : One Lillehei Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Senior Trade Compliance Analyst
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
audits....
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems as per 21CFR Part11 & US FDA....
Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these...
AIM Governance, Risk, Compliance Analyst Senior Hybrid
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
At Allianz Life, we are driven by our mission - we secure your future - and by our common goal of caring for tomorrow. We care for our employees by promoting an inclusive culture where everyone...
Compliance Analyst/ Compliance Analyst Senior - Financial Crimes Unit/AML Hybrid
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 6 days ago
At Allianz Life, we are driven by our mission - we secure your future - and by our common goal of caring for tomorrow. We care for our employees by promoting an inclusive culture where everyone...
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 8 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 8 days ago
Utilities Compliance Analyst 3.6 3.6 out of 5 stars Minneapolis, MN 55401 System One is actively recruiting for a Utilities Compliance Analyst for a long-term contract position located in...
Licensing and Regulatory Compliance Analyst
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 10 days ago
- Minneapolis, MN (14 miles from Maple Grove, MN)
- 10 days ago
Licensing and Regulatory Compliance Analyst Full-time Company Description We're the world's leading sports technology company, at the intersection between sports, media, and betting. More than...
- Saint Paul, MN (23 miles from Maple Grove, MN)
- 10 days ago
- Saint Paul, MN (23 miles from Maple Grove, MN)
- 10 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkTrade Compliance Analyst - Free Trade Agreements
- Maplewood, MN (24 miles from Maple Grove, MN)
- 11 days ago
- Maplewood, MN (24 miles from Maple Grove, MN)
- 11 days ago
Job Description: Job Title Trade Compliance Analyst Free Trade Agreements Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your...
Regulatory Compliance Specialist
- Rogers, MN (5 miles from Maple Grove, MN)
- 13 days ago
- Rogers, MN (5 miles from Maple Grove, MN)
- 13 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...
Demographic Data for Maple Grove, MN
Moving to Maple Grove, MN? Find some basic demographic data about Maple Grove, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Maple Grove, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Maple Grove, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Fraud Investigation
- Reimbursement
- 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
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- 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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