Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)

SystImmune is a leading clinical-stage biopharmaceutical company seeking a Regulatory Affairs leader to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution. The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions.

Requirements

• Bachelor’s degree or higher in Life Sciences, Pathology, Molecular Biology, or related field
• 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx
• Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD
• LTD
• 401(k) plan with a 50% company match of up to 3%
• Vesting schedule of only 5 years
• 15 PTO days per year
• Sick leave
• 11 paid holidays