Director Quality Regulatory Affairs. Job in Seattle WestCoast-Jobs

  • Job Reference: 462851109-2
  • Date Posted: 2 January 2022
  • Recruiter: proprio
  • Location: Seattle, Washington
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent

Job Description

We are seeking a Director of Regulatory & Quality to join our team. You will work with the leadership team on regulatory strategy, driving submissions while ensuring overall product quality. You will build a team and will be empowered to bring on expert SME consultants to enable you.


As the owner of the Regulatory & Quality department, you will be the champion and mentor inside the organization for overall quality processes.


Responsibilities

• Work closely with product development leaders to ensure robust development processes

• Create and maintain a practical QMS to meet FDA and EU regulations

• Design meaningful quality data measures and monitoring programs

• Manage Quality Engineers, SME consultants, and budgets

• Drive overall quality management with contract manufacturing partners

• Work with leadership team (and Consultant SMEs as needed) to establish and execute regulatory strategy

• Manage regulatory submissions and FDA correspondence

• Work closely with Clinical department on clinical strategy to support regulatory submissions


Qualifications

• B.S. in Engineering, Technology or Science

• 10+ years of experience building and/or supporting quality systems in a medical device company

• 5+ years of increasing responsibility within the Regulatory/Quality function of a medical device company

• 3+ years of experience managing personnel

• Working knowledge of medical device hardware and software lifecycle best practices

• Strong understanding of FDA regulations and ISO 13485

• Experience submitting 510(k) applications to the FDA