Regulatory Affairs Specialist Jobs in Chaska, 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.
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (16 miles from Chaska, MN)
- 2 days ago
- Plymouth, MN (16 miles from Chaska, MN)
- 2 days ago
The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....
Regulatory Affairs Coordinator
- Eden Prairie, MN (12 miles from Chaska, MN)
- 1 day ago
- Eden Prairie, MN (12 miles from Chaska, MN)
- 1 day ago
Shift Start/End Time: 800am - 430pm central - FT hours **start and end time can be flexible The Regulatory Affairs Coordinator Eden Prairie, MN or Telecommuters who are qualified will manage...
Principal Regulatory Affairs Specialist
- Maple Grove, MN (22 miles from Chaska, MN)
- 2 days ago
- Maple Grove, MN (22 miles from Chaska, MN)
- 2 days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Senior Regulatory Affairs Specialist
- Minneapolis, MN (21 miles from Chaska, MN)
- 2 days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 2 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Sr. Business System Compliance Analyst
- Plymouth, MN (16 miles from Chaska, MN)
- 6 days ago
- Plymouth, MN (16 miles from Chaska, MN)
- 6 days ago
Abbott Sr. Business System Compliance Analyst in Plymouth , Minnesota Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing...
Principal Regulatory Affairs Specialist - Hybrid
- Minneapolis, MN (21 miles from Chaska, MN)
- 15 days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 15 days ago
Supports internal audits and external inspections. Assists team members to support worldwide licenses and registrations as needed. Monitors and improves tracking/control systems....
Senior Regulatory Affairs Specialist (on-site)
- Plymouth, MN (16 miles from Chaska, MN)
- 27 days ago
- Plymouth, MN (16 miles from Chaska, MN)
- 27 days ago
The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN....
Senior Medical Affairs Compliance Analyst
- Eagan, MN (23 miles from Chaska, MN)
- 27 days ago
- Eagan, MN (23 miles from Chaska, MN)
- 27 days ago
About Blue Cross and Blue Shield of Minnesota At Blue Cross and Blue Shield of Minnesota, we are committed to paving the way for everyone to achieve their healthiest life. We are looking for...
Sr Substation Compliance Analyst
- Minneapolis, MN (21 miles from Chaska, MN)
- 28 days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 28 days ago
The primary responsibility of this position is the daily management and administration of Substation processes and documentation required to support the Xcel Energy regulatory oversight and...
Medical Affairs Compliance Analyst Sr
- Eagan, MN (23 miles from Chaska, MN)
- 28 days ago
- Eagan, MN (23 miles from Chaska, MN)
- 28 days ago
About Blue Cross and Blue Shield of Minnesota At Blue Cross and Blue Shield of Minnesota, we are committed to paving the way for everyone to achieve their healthiest life. We are looking for...
Senior Regulatory Affairs Specialist
- Plymouth, MN (16 miles from Chaska, MN)
- 30+ days ago
- Plymouth, MN (16 miles from Chaska, MN)
- 30+ days ago
Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers....
Senior Regulatory Affairs Specialists
- Minneapolis, MN (21 miles from Chaska, MN)
- 30+ days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 30+ days ago
Ensure product adherence to government and industry standards including Quality System Regulation (QSR 21 CFR 820), ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485 and ISO 14971....
Sr Regulatory Compliance Specialist
- Minneapolis, MN (21 miles from Chaska, MN)
- 30+ days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 30+ days ago
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
- Minneapolis, MN (21 miles from Chaska, MN)
- 45+ days ago
- Minneapolis, MN (21 miles from Chaska, MN)
- 45+ 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...
- Chanhassen, MN (4 miles from Chaska, MN)
- 45+ days ago
- Chanhassen, MN (4 miles from Chaska, MN)
- 45+ days ago
Internal Audit Department Support: Support the Internal Audit team in other compliance-related tasks as needed....
Demographic Data for Chaska, MN
Moving to Chaska, MN? Find some basic demographic data about Chaska, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Chaska, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Chaska, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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