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Skyline Medical, a wholly owned subsidiary of Predictive Oncology, is looking for a Quality Assurance & Regulatory Manager in Eagan, MN. This position will lead the quality and regulatory functions for our revolutionary STREAMWAY medical waste and fluid management system. This position is responsible for developing and maintaining all required documentation to support the Company’s medical device products and processes. This position will be instrumental in maintaining ISO 13485 Certification, maintaining regulatory compliance regarding the FDA and Health Canada, and maintaining CE Mark status.
Key Responsibilities
The QA & Regulatory Manager will:
Ensure processes necessary for the quality management system are documented and effectively maintained,
Report to top management on the performance and effectiveness of the quality management system and
any need for improvement,
Ensure the promotion of awareness of applicable regulatory requirements and quality management system
requirements throughout the organization.
Qualifications
Competencies
Contractor
Hospital
$119k-149k (estimate)
09/08/2024
10/03/2024
skylinemedicalgroup.com
NASHVILLE, TN
<25
2006
$5M - $10M
Hospital
Our internal medicine doctors in Nashville are dedicated to preventing, diagnosing and treating diseases that affect adults.