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Описание: |
Yalantis is looking for an experienced Compliance Engineer to join a healthcare pre-sales engagement as an independent consultant.
You’ll collaborate with our engineering team and the client to define the compliance strategy for a next-generation critical care ventilator intended for FDA 510(k) submission.
This is a part-time consulting engagement, focused on compliance planning, regulatory strategy, verification planning, and project estimation.
What you will do:
* Map system and board requirements to IEC 62304, IEC 60601 and FDA evidence needs; establish the Class C / Class B boundaries to be resolved.
* Author the standards coverage matrix — what we cover, what is shared, what stays with the client, by which method, accepted at which gate.
* Define the IEC 62304 evidence structure and SOUP approach (RTOS, Linux BSP, Qt, third-party libraries, battery-pack BMS): versions, anomaly review, update and revalidation policy.
* Produce ISO 14971 design inputs: failure modes, safe-state categories, single-fault tolerance — as inputs to the client’s risk management file.
* Draft the verification and pre-compliance test plan: unit / integration / system verification, EMC, hipot, thermal imaging, 30-day continuous soak — and the split between our bench and the accredited lab.
* Set up traceability, the verification matrix and the compliance checklist in a structure compatible with the client’s DHF.
* Own the compliance line of the phased estimate: effort per gate, plus a quantified list of cost and schedule optimisation options with the risk attached to each.
* Contribute regulatory risks, assumptions and dependencies to the program register
Client workshops.
* Requirements and system context — compliance priorities.
* Compliance strategy — IEC 62304 lifecycle, SOUP, ISO 14971, 60601 and 60601-1-8 design implications.
* Verification and pre-compliance planning — EMC, hipot, thermal, soak, DHF handover package.
* Estimate walkthrough — defend the compliance scope and effort with the client’s engineering team.
Must have:
* 5+ years in medical device compliance, including at least 1 full cycle on a Class II life-supporting or life-sustaining device from design inputs through pre-compliance.
* Working command of IEC 60601-1: MOPP/MOOP, creepage and clearance, Type BF applied parts, isolation barriers, dielectric strength testing.
* IEC 60601-1-2 (EMC) — able to read a layout for EMC risk and issue constraints before routing, not review after.
* IEC 62304 for Class C: lifecycle, requirements-to-design-to-verification traceability, software item classification and segregation, SOUP management.
* ISO 14971 applied at design level — FMEA, safe states, single-fault tolerance.
* ISO 13485 QMS, comfortable operating under a client’s QMS and supporting internal and external audits.
* FDA design controls (21 CFR 820.30), DHF structure and 510(k) — clear on what a submission needs from a development vendor.
* Hands-on planning and support of pre-compliance testing (EMC, dielectric strength, thermal) and work with accredited test laboratories.
* Able to estimate your own effort per phase and defend the number in front of a client’s technical team.
* English at B2/C1 level.
Nice to have:
* ISO 80601-2-12, IEC 60601-1-8 alarm systems.
* Contribution to a 510(k) that reached clearance.
* IEC 62366 usability engineering — enough to hold the boundary correctly.
* IEC 81001-5-1 and FDA premarket cybersecurity guidance.
* EU MDR technical documentation, in case of market expansion.
* Enough familiarity with MISRA C:2012 and static-memory-allocation evidence to accept firmware records on substance rather than on filename.
Please note that feedback on the results of the CV review will be provided only in the event of a decision to consider your candidacy further.
Otherwise, your data will be retained in the company’s CV database, and we will gladly contact you if a suitable vacancy becomes available. The consideration period is 7 working days.
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