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Salary: USD 150,000 - 165,000 / annual
As Senior Regulatory & Quality Systems Engineer at quip, you are the strategic lead for product integrity and regulatory compliance. You own quip's regulatory strategy across current and future markets, govern contract manufacturers' quality systems, and serve as the sign-off authority in new product development.
Key responsibilities include:
**Regulatory & Safety:** Ensure all products comply with legal and regulatory requirements across markets. Own and maintain the regulatory matrix, develop regulatory markings and safety language, substantiate product claims, and manage regulatory portals (FDA, Intertek, Bluetooth SIG, etc.).
**FDA Compliance:** Own end-to-end FDA compliance for Class I medical devices, including Medical Device Reporting (MDR), complaint file maintenance (21 CFR 820.198), UDI/GUDID compliance, and FDA establishment registration and device listing.
**Supplier Governance:** Audit and oversee contract manufacturers' Quality Management Systems for ISO 13485 and ISO 9001 adherence. Own CAPA and deviation processes, conduct supplier audits, and track performance systematically.
**New Product Development:** Serve as required quality sign-off authority. Ensure records are complete and defensible before launch.
**Risk Management:** Own quip's Risk Management File incorporating FMEA analysis. Confirm residual risks are acceptable and properly controlled.
**Validation & Testing:** Provide regulatory sign-off on Design and Manufacturing Validation test plans and reports. Ensure documentation meets quality, safety, and regulatory requirements.
**Escalation & Process Improvement:** Act as escalation point for sensitive customer issues. Identify gaps in quality/regulatory processes, develop SOPs, and train teams. Manage document control, routing, approval, and archiving of critical documents.
You will report into the Hardware team with accountability to the Consumables Lead. This role requires someone who thinks naturally in systems, audit trails, and root causes—ready to build quip's regulatory and quality infrastructure as the company expands into new categories and markets.
