Regulatory & Quality Systems Engineer
US$150,000 – US$165,000 / yr base salary
Posted 9 Sep 2026
Advertised as “Sr. Regulatory & Quality Systems Engineer”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 6+ yrs
- Management level
- Individual contributor
- Employment
- Hybrid
- Contract
- Full-time
- Visa sponsorship
- Not offered
| Base salary | US$150,000 – US$165,000 / yr |
|---|
Field of studyBiomedical Engineering, Mechanical Engineering
Study levelMaster's
DESCRIPTION
As Sr. Regulatory & Quality Systems Engineer, you are the strategic lead for quip's product integrity — the person who ensures every product we ship is safe, compliant, and defensible, from first regulatory filing through post-market surveillance. You'll own our regulatory strategy across current and future markets, govern our contract manufacturers' quality systems, and act as the sign-off authority in new product development. This role suits someone who thinks in systems and audit trails as naturally as they think in root causes, and who's ready to build (not just maintain) quip's regulatory and quality infrastructure as we expand into new categories and markets. You will report into the Hardware team but also have accountability into the Consumables Lead day-to-day.
This role is full time on-site Monday–Thursday in our DUMBO, Brooklyn design studio, with Fridays remote.
Base Salary: $150k-$165K
This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these considerations.
Work Authorization: This position is not eligible for immigration sponsorship. Applicants must be currently authorized to work in the United States and must not require quip to initiate, transfer, maintain, extend, or otherwise support an employment-based immigration status now or in the future. This includes employer action related to a change or transfer of sponsoring employer.
RESPONSIBILITIES
Regulatory & Safety
- Ensure all quip products comply with relevant legal and regulatory requirements
- Own and maintain the regulatory matrix across current and future expansion markets
- Own development of regulatory markings, serialization, and product safety/warning language across printed and digital materials
- Ensure product claims are substantiated by the engineering/product team and aligned with marketing needs; facilitate third-party testing when necessary
- Own regulatory portals (Intertek, WercSmart, Bluetooth SIG, FDA, etc.) and act as point person to keep information current and retrievable
FDA Compliance & Reporting
- Own quip's end-to-end FDA compliance program for its Class I devices
- Own US FDA Medical Device Reporting (MDR) compliance