Sr Manager, Regulatory Affairs (Medtech)

TL;DR

Sr Manager, Regulatory Affairs (Medtech): Leading regulatory execution for a health and wellness platform blending digital health and medical technologies with an accent on FDA premarket applications and ecosystem compliance. Focus on authoring 510(k) submissions, managing agency relations, and scaling a technical regulatory playbook.

Location: Remote (Must be US-based)

Salary: $170,000 – $200,000

Company

A leading public health and wellness platform redefining healthcare through personalized, affordable, and accessible care.

What you will do

• Own the end-to-end lifecycle of FDA premarket applications, specifically authoring and steering 510(k) submissions to clearance.
• Operationalize and maintain compliance across diverse jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
• Serve as the primary regulatory point of contact for federal and state agency audits, inspections, or submission inquiries.
• Build and scale the Technical Playbook for medical product operations to ensure alignment with shifting regulations.

Requirements

• 12+ years in Regulatory Affairs, with a strong emphasis on the Medical Device industry and IVDs.
• Proven track record of personally authoring multiple successful FDA 510(k) clearances, specifically for IVDs.
• Deep hands-on experience navigating FDA, DEA, CMS/CLIA, and FTC regulations.
• Advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent experience.
• Must be based in the US to be eligible for the stated compensation range.
• Ability to operate autonomously in a high-growth environment with quickly pivoting product roadmaps.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• 401k with employer matching and Employee Stock Purchase Program (ESPP).
• Regular offsite team retreats.