Regulatory Affairs Specialist Jobs in Maple Plain, 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 Analyst - Nationwide Remote
- Minnetonka, MN (12 miles from Maple Plain, MN)
- 9 hours ago
- Minnetonka, MN (12 miles from Maple Plain, MN)
- 9 hours ago
At UnitedHealthcare, we’re simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of...
Remote WorkSenior Trade Compliance Analyst
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 days ago
audits....
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 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 (20 miles from Maple Plain, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 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...
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AIM Governance, Risk, Compliance Analyst Senior Hybrid
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 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 (20 miles from Maple Plain, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 4 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 (20 miles from Maple Plain, MN)
- 6 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 6 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 (20 miles from Maple Plain, MN)
- 8 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 8 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...
Regulatory Compliance Specialist
- Rogers, MN (13 miles from Maple Plain, MN)
- 11 days ago
- Rogers, MN (13 miles from Maple Plain, MN)
- 11 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...
Principal Regulatory Affairs Specialist
- Eden Prairie, MN (14 miles from Maple Plain, MN)
- 19 days ago
- Eden Prairie, MN (14 miles from Maple Plain, MN)
- 19 days ago
Principal Regulatory Affairs Specialist LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies?...
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 20 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 20 days ago
Pay Range- $42/hr. -$45hr. Theyre looking for an experienced regulatory affairs professional who can independently manage post-market submissions assess changes, and collaborate across teams....
Senior Compliance Analyst (R25_0000000223)
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 20 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 20 days ago
We have an exciting opportunity as a Senior Compliance Analyst at Ameriprise! In this role you will assist in ensuring communications satisfy regulatory and corporate requirements; support...
- Bloomington, MN (22 miles from Maple Plain, MN)
- 24 days ago
- Bloomington, MN (22 miles from Maple Plain, MN)
- 24 days ago
Security Compliance Analyst#25-13246 Bloomington, MN Fully Remote Contract Starts 4/28/2025 Ends 1/14/2026 Job Description Genesis10 is currently looking for a Security Compliance Analyst for an...
Remote Work- Minneapolis, MN (20 miles from Maple Plain, MN)
- 24 days ago
- Minneapolis, MN (20 miles from Maple Plain, MN)
- 24 days ago
Regulatory Affairs Specialist is responsible for creating and assuring compliance of federally regulated product label information, including nutrition, ingredient declaration, allergens, claims and...
- Bloomington, MN (22 miles from Maple Plain, MN)
- 30+ days ago
- Bloomington, MN (22 miles from Maple Plain, MN)
- 30+ days ago
SOC 2 Compliance Analyst#25-13246 Bloomington, MN Fully Remote Contract Starts 4/14/2025 Ends 1/14/2026 Job Description Genesis10 is currently looking for a SOC 2 Compliance Analyst for an 8 month...
Remote WorkDemographic Data for Maple Plain, MN
Moving to Maple Plain, MN? Find some basic demographic data about Maple Plain, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Maple Plain, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Maple Plain, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- 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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