Director of Quality

Irvine Permanent USD140,000 - USD160,000
  • Leadership opportunity with Growing Clinical Start-up
  • Support for all phases of the clinical programs internationally and the US

About Our Client

My client specializes in the manufacturing of exciting advances in ophthalmology now allow patients to choose corneal inlays to correct presbyopia. There are a Start-up who is expanding into new markets and is continuing to grow out their Quality Department.

Job Description

The responsibilities of the Director of Quality & Regulatory are

  • Lead clinical research team for assigned programs
  • Development and execution of the clinical programs
  • Development of clinical budget for the programs
  • Work closely with Medical Monitor to design and conduct clinical programs
  • Company liaison with thought leaders and investigators
  • Oversee the analysis, interpretation and reporting of study results and preparation of the clinical study report in conjunction with the Medical Monitor
  • Interact with regulatory agencies under direction of the Regulatory Affairs department.
  • Assist with regulatory updates including annual IDE reports
  • Presentations to advisory committees, investigators and scientific meetings
  • Manuscript and poster preparation
  • Cross-functional collaboration and alignment for clinical programs across regulatory, development, operations and commercial teams.



MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The successful Director of Quality & Regulatory will

  • Lead clinical research team for assigned programs
  • Development and execution of the clinical programs
  • Development of clinical budget for the programs
  • Work closely with Medical Monitor to design and conduct clinical programs
  • Company liaison with thought leaders and investigators
  • Oversee the analysis, interpretation and reporting of study results and preparation of the clinical study report in conjunction with the Medical Monitor
  • Interact with regulatory agencies under direction of the Regulatory Affairs department.
  • Assist with regulatory updates including annual IDE reports
  • Presentations to advisory committees, investigators and scientific meetings
  • Manuscript and poster preparation
  • Cross-functional collaboration and alignment for clinical programs across regulatory, development, operations and commercial teams.

What's on Offer

My client offers a competitive compensation, benefits, and equity in a growing start-up.

Contact
Daniel Hall
Quote job ref
JN-042022-5416608

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
Irvine
Contract Type
Permanent
Consultant name
Daniel Hall
Job Reference
JN-042022-5416608