VP Regulatory / Clinical Affairs

Our client is an early stage start-up developing a disruptive technology in the Oncology space. (Strong base / bonus, and equity.) They are seeking a Clinical Affairs professional to help lead their product development and regulatory approval efforts. (Position will report to CEO.)

This is a great opportunity to get in on the ground floor of an exciting new company with an innovative device, developing a new treatment modality in oncology (glioblastoma / brain tumors first) .

Compensation: $200K-$300K (negotiable based on experience), equity

Responsibilities:

• Help develop approval strategies, create, edit, and submit regulatory documents (PMA, 510(k), IDE, CE, etc.) to applicable authorities (FDA, Health Canada, etc.)
• Apply knowledge of scientific, technical, regulatory and business issues to execute on product strategy throughout development, commercialization and life of product.
• Assists with preparation and processing of various regulatory documentation through the FDA and applicable regulatory review committees

Qualifications:

• BA/BS degree required
• 10+ years of experience working as a Clinical / Regulatory Affairs professional in the medical device space required, oncology / brain tumor experience a huge plus!
• Early stage Start-up experience highly desired
• Experience in the oncology space, preferably experience in brain tumors.