Senior Regulatory & Quality Systems Engineer FDA/ISO Expert

quip; New York (NY); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

DUMBO Brooklyn office

Competitive medical benefits

Equity (as applicable)

Job summary

quip NYC is seeking a Sr. Regulatory & Quality Systems Engineer to lead product integrity from regulatory filing through post-market surveillance.

You will own regulatory strategy across markets and govern contract manufacturers' quality systems, and sign off on new product development, reporting to the Hardware team with accountability to the Consumables Lead. You’ll report into the Hardware team, align with the Consumables Lead, and sign off on new product development.

Qualifications

• 6+ years experience in Regulatory and/or Quality Engineering / Systems management.
• Familiarity with FDA MDR, UDI/GUDID, and establishment registration & listing for Class I devices.
• Strong communication skills to present quality risks to executive leadership.
• Willingness to travel internationally 2–3 times per year to be on-site at suppliers.

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 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 keep information current.

Skills

Regulatory compliance

Quality systems

Auditing

Communication skills

Cross-functional collaboration

Travel readiness

Education

Bachelor’s or Master’s in Mechanical or Biomedical Engineering

Job description

quip NYC is seeking a Sr. Regulatory & Quality Systems Engineer to lead product integrity from regulatory filing through post-market surveillance.

You will own regulatory strategy across markets and govern contract manufacturers' quality systems, and sign off on new product development, reporting to the Hardware team with accountability to the Consumables Lead. You’ll report into the Hardware team, align with the Consumables Lead, and sign off on new product development.