Director of Quality and Regulatory Affairs

Director of Quality and Regulatory Affairs

Director of Quality and Regulatory Affairs

Location: Pittsburgh, PA 

Salary Range: $120,000 – $150,000

The Rowland Group is in search of a Director of Quality and Regulatory Affairs for a medical device manufacturer in Pittsburgh, PA! This position is responsible for Directing and managing the development, implementation and continual improvement of an effective quality system.

Responsibilities:

  • Direct the development, implementation, management and continual improvement of an effective quality management system at four geographic sites
  • Function as the primary contact for regulatory submissions (primarily FDA 510k) and associated compliance within the company
  • Serve as a quality system and regulatory resource to the organization by providing counseling and oversight that comply with applicable standards and regulations
  • Act as the official correspondent to the FDA and other regulatory and standard organizations in maintaining competency in FDA quality system regulations and as the Management Representative for Quality
  • Administrator of non-conformances, CAPA and complaint systems
  • Primary contact for external regulatory audits

Requirements:

  • 8+ years’ experience establishing, implementing and directing a best-in-class QA/RA program
  • 3+ years in a management role
  • Bachelor’s degree required; Master’s degree desirable
  • Certified Quality Engineer, Six Sigma training, or similar with submission of 510ks for Class II devices, ultrasound devices a plus

 

The Rowland Group is an Equal Opportunity Employer. M/F/Disability/Vet 24060

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