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Director-Quality Assurance & Regulatory Affairs

Location
South Bend, Indiana
Job Type
Permanent
Posted
1 Oct 2021
Director- Quality Assurance & Regulatory Affairs
Would you like to be an outstanding Quality Assurance & Regulatory Affairs Director with a company that values its employees at the same time as delivering innovative materials and digital solutions for the dental market of today?
  • Ensure all company Quality Assurance and Regulatory Affairs Policies are established, communicated, and continually met for all employees while maintaining compliance with all South Bend, Indiana facility's products and services.
  • Develop policy and lead the planning, development, and implementation of new methods and procedures designed to improve unit performance, minimize operating costs and effect greater utilization of labor and materials.
Salary up to $150k Hybrid schedule once established Excellent Benefits 10% Annual Bonus
Quality Assurance & Regulatory Affairs Director Responsibilities
  • Full scope of Quality Assurance/Regulatory Affairs staff functions
  • All personal matters
  • Performance Management Process
  • ISO 13485 MDSAP, FDA and Health Canada QS Audits
  • Q5 compliance/regulatory activities
  • New product submissions (510(k, Health Canada clearance
  • US FDA (MDR) and Canadian Health Authorities reporting
  • Direct validation testing and specifications development
  • Assure appropriate control systems and procedures are in place
  • Participate in product development
  • Quality System audits
Quality Assurance & Regulatory Affairs Director Qualifications
  • BS or MS degree in one of the life sciences
  • 7-10 years experience in Quality Assurance and Regulatory Affairs or a related field
  • Product development experience as it relates to Quality (manufacturing and marketing of medical devices and drug products preferred)
  • Knowledge and understanding of
    • FDA CFR 21 Part 820 and ISO 13485 MDSAP Standards
    • Medical device manufacturing
    • FDA and Health Canada
    • US FDA (FURLS, MDL) and Health Canada establishment registration, product licensing, 510(k) submission processes and requirements
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Details

  • Job Reference: 386581289-2
  • Date Posted: 1 October 2021
  • Recruiter: HealthCare Recruiters International
  • Location: South Bend, Indiana
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent