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Director, Quality Systems & Regulatory Affairs (Remote - East Coast)

📅 Jul 6
Quality Management System (qms)Eqms AdministrationISO 13485FDA Quality System Regulation

📜 Description

  • Serve as system owner and business lead for the organization's eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption.
  • Assess current eQMS utilization and develop a roadmap for full implementation and process maturity.
  • Own and administer day-to-day QMS and eQMS activities and processes.
  • Lead continual improvement initiatives across quality system processes and documentation.
  • Lead comprehensive audits of controlled documentation and quality records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies.

🛠️ Requirements

  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required.
  • 8–12+ years of progressive Quality and Regulatory Affairs experience within medical devices.
  • Demonstrated experience serving as lead quality or regulatory representative during notified body audits and regulatory inspections.
  • Proven experience owning, implementing, or significantly improving an electronic QMS platform; Greenlight Guru experience strongly preferred.
  • Experience independently leading FDA submissions and EU MDR activities.

Benefits

  • Health insurance (80% employer-paid)
  • Employer-paid Dental and Vision
  • Group Life Insurance
  • Paid PTO
  • Paid company holidays
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