Senior Manager, Post Market Surveillance

Merit Medical Systems

Onsite
Post market surveillance documentation processes
Health hazard evaluation (hhe) processes
Field correction action and recall (fca) processes
Merit Medical Systems is seeking a Senior Manager for Post Market Surveillance to oversee quality management processes related to medical devices. The ideal candidate should have extensive experience in the medical device industry, particularly in post-market surveillance, and possess strong leadership and regulatory knowledge

Job Summary

  • The role involves managing and supervising all post market surveillance personnel including hiring, training, and performance evaluation.
  • Candidates must ensure compliant quality management sub-systems across global sites while maintaining adherence to FDA and EU MDR regulations.
  • Merit Medical offers benefits including multiple shift options, onsite medical clinic, cafeteria access, and a 401K plan.

Matching Summary

Match Score: 85

Merit Medical Systems is seeking a Senior Manager for Post Market Surveillance to oversee quality management processes related to medical devices. The ideal candidate should have extensive experience in the medical device industry, particularly in post-market surveillance, and possess strong leadership and regulatory knowledge.

Skills & Requirements

Must-have

  • Post Market Surveillance documentation processes
  • Health Hazard Evaluation (HHE) Processes
  • Field Correction Action and Recall (FCA) Processes
  • FDA regulations 21 CFR 803 806 820
  • ISO 13485 Quality System Standards
  • Supervisory leadership experience

Nice-to-have

  • Lean and Six-Sigma resources and tools
  • Proven track record of international team leadership
  • Credentialed Clinical professional or RN background
  • ASQ Certifications CQE or CBA
  • RAC Global Regulatory Affairs Certification

Key Requirements

  • Bachelor's degree in quality engineering, science, nursing or equivalent
  • 12 years medical device industry experience with 7 years in leadership
  • Knowledge of ISO 14971 Risk Management requirements
  • Experience with electronic data management systems like Pilgrim or Oracle

Work Rights

Not specified

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