Regulatory Affairs Specialist Jobs in Shakopee, 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 (20 miles from Shakopee, MN)
- 16 hours ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 16 hours ago
System One is actively recruiting for a Utilities Compliance Analyst for a long-term contract position located in Minnesota. Utilities Compliance Analyst will work under the Director of Identity...
Licensing and Regulatory Compliance Analyst
- Minneapolis, MN (20 miles from Shakopee, MN)
- 2 days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 2 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...
Principal Regulatory Affairs Specialist
- Eden Prairie, MN (12 miles from Shakopee, MN)
- 13 days ago
- Eden Prairie, MN (12 miles from Shakopee, MN)
- 13 days ago
Principal Regulatory Affairs Specialist LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies?...
- Minneapolis, MN (20 miles from Shakopee, MN)
- 14 days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 14 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 Shakopee, MN)
- 14 days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 14 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 (13 miles from Shakopee, MN)
- 18 days ago
- Bloomington, MN (13 miles from Shakopee, MN)
- 18 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 Shakopee, MN)
- 18 days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 18 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 (13 miles from Shakopee, MN)
- 25 days ago
- Bloomington, MN (13 miles from Shakopee, MN)
- 25 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 WorkSenior Regulatory Affairs Specialist
- Burnsville, MN (11 miles from Shakopee, MN)
- 27 days ago
- Burnsville, MN (11 miles from Shakopee, MN)
- 27 days ago
Support company compliance, including practical guidance and expertise with quality management system regulations....
Advertising Review Compliance Analyst/Senior Analyst/Specialist Hybrid
- Minneapolis, MN (20 miles from Shakopee, MN)
- 30+ days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 30+ 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...
Sr. Business System Compliance Analyst
- Plymouth, MN (18 miles from Shakopee, MN)
- 45+ days ago
- Plymouth, MN (18 miles from Shakopee, MN)
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Senior Regulatory Affairs Specialist (on-site)
- Plymouth, MN (18 miles from Shakopee, MN)
- 60+ days ago
- Plymouth, MN (18 miles from Shakopee, MN)
- 60+ days ago
The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN....
- Minneapolis, MN (20 miles from Shakopee, MN)
- 30+ days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 30+ days ago
UnitedHealth Group is a health care and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary...
Remote WorkSenior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (18 miles from Shakopee, MN)
- 45+ days ago
- Plymouth, MN (18 miles from Shakopee, MN)
- 45+ days ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL...
- Minneapolis, MN (20 miles from Shakopee, MN)
- 45+ days ago
- Minneapolis, MN (20 miles from Shakopee, MN)
- 45+ days ago
Dorsey & Whitney LLP is seeking an associate with two to five years of environmental, natural resources, compliance, or regulatory law experience to join the Regulatory Affairs Practice Group in...
Demographic Data for Shakopee, MN
Moving to Shakopee, MN? Find some basic demographic data about Shakopee, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Shakopee, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Shakopee, 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
- 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
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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