Senior Program Manager — Class III Implantable Neuromodulation

Realeve is an early-stage medical device company developing a Class III active implantable neuromodulation device. The company is at the critical stage of finalizing manufacturing processes and requires experienced program management leadership to guide the program through regulatory approval.

We are seeking a Senior Program Manager with direct, hands‑on experience taking a Class III active implantable device from manufacturing process finalization through DeNovo submission and approval. This individual will own the intersection of manufacturing operations, quality systems, and regulatory strategy — ensuring that all manufacturing data is properly captured, validated, and translated into DeNovo Module submissions.

• Lead and oversee manufacturing process validation (IQ/OQ/PQ) through to completion
• Manage Design History File (DHF) and Device Master Record (DMR) during scale‑up
• Direct verification and validation (V&V) protocol development and execution
• Maintain risk management file (ISO 14971) with manufacturing linkage
• Interface cross‑functionally across engineering, quality, regulatory, and clinical teams
• Manage timelines, milestones, and deliverables to support DeNovo filing schedule

• Minimum 7–10 years medical device program management experience
• Direct ownership of manufacturing process validation (IQ/OQ/PQ) through DeNovo submission — required
• Deep familiarity with 21 CFR Part 820 (Quality System Regulation) and ISO 13485
• DeNovo Module 3 and/or Module 4 preparation experience — required
• Working knowledge of ISO 10993 (biocompatibility) and sterilization validation
• Experience with FDA Q‑Sub (pre‑submission) process strongly preferred

• Contract manufacturing organization (CMO) interface experience — Integer Holdings, Lake Region Medical, or similar
• Experience in early‑stage or startup device company environments