I am working with a really exciting and well funded start up to recruit a QA/RA Manager to join their team. The RA/QA Manager will have overall responsibility for Quality and Regulatory within the company ensuring compliance to all related requirements, governing Regulatory Standards and guidance.
Contact me for a confidential discussion and detailed job description.
Knowledge and skills required
Bachelor's degree from accredited college in a scientific or engineering discipline. Master’s Degree or PhD preferred.
At least 5 years of management and leadership experience in the medical device industry in both Quality/design Assurance and Regulatory Affairs roles.
A track record of success with IDE and FDA 510k submissions. Substantial direct interaction with FDA including conduct of meetings on proposed submissions, negotiating clinical trial and submission requirements and dealing with FDA questions while in process.
Highly experienced in developing regulatory approval strategies for new products, preparing regulatory submissions and assuring timely approval.
Excellent interpersonal skills and the ability to work and manage effectively in a team environment.
Highly organized with the ability to manage complex projects.
Possess the analytical skills needed to conduct research, analyse data and write technical and/or legal documents.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Excellent Salary & Benefits.
For more information on the role and a confidential discussion please contact Chris O'Toole.