Enterprise Business Development Lead

About the Company:

Kru Labs builds AI accountability infrastructure for regulated enterprises, starting with AI-enabled medical devices and Software as a Medical Device (SaMD). Our products give manufacturers continuous oversight of the AI in their products and the regulatory evidence to prove it. We are an early-stage, founder-led company. You will be one of our first hires.

Ensure all your application information is up to date and in order before applying for this opportunity.

Position Summary:

We are hiring an Enterprise BD Lead to sign our first design partners among medical device manufacturers. Design partners work with us closely to shape the product, pilot it on real devices and become our first reference customers. This is a door-opening role. We need someone whose network already reaches the people who own AI, quality and regulatory decisions at device companies — and who can turn those relationships into signed pilots. You will report to the founders and work alongside them on every deal.

Responsibilities:

• Build and work a target list of medical device manufacturers with AI/ML-enabled products, from growth-stage SaMD companies to enterprise device makers.

• Open warm conversations with heads of Regulatory Affairs, Quality, Clinical/Data Science, Product and Engineering.

• Run discovery to understand how each company monitors AI in the field, documents changes and prepares for FDA and EU MDR/AI Act scrutiny.

• Structure and close design-partner agreements: pilot scope, success criteria, timeline, data access and path to a paid contract.

• Bring customer insight back to the product team and help shape the roadmap.

• Represent Kru Labs at industry events, accelerators and partner programs (e.g. MedTech Innovator, AdvaMed, RAPS).

• Build the early BD playbook, CRM and pipeline reporting we will scale from.

Qualifications:

• 8+ years in enterprise sales or business development, with at least 5 selling into medical device or medtech companies.

• An active network of decision-makers at device manufacturers — people who will take your call.

• A track record of closing complex, multi-stakeholder deals, ideally including pilots or design partnerships for early products.

• Working fluency in the device regulatory landscape: FDA 510(k)/De Novo/PMA, QMS (ISO 13485, 21 CFR 820) and how AI-enabled devices are reviewed.

• Comfort selling a new category to technical and regulatory buyers.

• Startup temperament: you build process from scratch and are energized by ambiguity.

Nice to Haves:

• Experience selling software, SaaS or data/AI tools (not only hardware) into device companies.

• Prior roles at a QMS, eQMS or regulatory software vendor.

• Relationships with medtech VCs, accelerators or industry associations.

• Background in regulatory affairs, quality or clinical engineering.

Success in the First 6 Months:

• 3–5 signed design-partner agreements with medical device manufacturers.

• A qualified pipeline of 20+ target accounts with named champions.

• At least one partner willing to serve as a public reference or case study. xhyhwjd

• A repeatable outreach and discovery process the next BD hire can follow.