Opportunity to join and lead the innovative diagnostics department of one of the world's leading manufacturers and contributors to treating diseases in the oncology space. Heavily funded, this division looks to gain regulatory approval for some of the most advanced diagnostic products currently in development, and are looking for a leader dedicated to patient care to lead the strategy and submissions for this talented division.

Primary Responsibilities

• Direct all activities relating to US FDA and analogous international regulatory compliance, such as clinical research and pre-clearance testing for new diagnostic and CDx submissions.
• Implement company wide CDx and Precision Medicine regulatory strategy and define the processes based off previous experiences.
• Develop and implement effective strategies for obtaining necessary regulatory approvals to bring products to market with optimum cost effectiveness and compliance.

Experience Required:

• Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline
• 10+ years of experience in the Medical Devices, Biotech, or Diagnostics industry.
• Prior exposure to IVDs/CDx is a desirable
• Managed regulatory teams through successful submissions for global organizations.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.