What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You look after what users tell us went wrong after a device shipped, and make sure the right people hear it.
You take in complaints, investigate them, decide whether an event is reportable and to whom, and trend the results back into risk and CAPA. The reportability decision runs on its own clock and on the information available — it is made and documented within its timeline, including the decision not to report, and the investigation refines the picture afterwards. Waiting for the investigation to conclude is the most common way a timeline is missed.
You are the organisation’s hearing. A signal missed here becomes a recall later, and the record of what you noticed is the defence. The harder discipline is the one nobody audits directly: making sure what you learn reaches the design and the risk file rather than accumulating as closed complaints. A vigilance function that reports accurately and changes nothing upstream has documented a problem rather than reduced it.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
In post-market surveillance, downstream of every marketed device and upstream of design change.
- Product release and distribution
- Customer, clinician and field-service reports
- Risk file updates and design change
- CAPA and, where warranted, field action
- Complete complaint intake from the field
- Device history and returned-product analysis
- The current risk file
- Design assurance (for post-market risk input)
- Regulatory Affairs (for reportability and field action)
- Complaint investigation to a real cause
- The reportability rationale, whichever way it lands
- Post-market trending and its escalation
- Deciding the design remedy — design assurance and R&D own that
- Submitting the field action — Regulatory Affairs owns that
- Regulatory Affairs and QA management
- Immediately, for any event suggesting a safety issue in a marketed device
- Complaint records and investigations
- Reportability decisions and their rationale
- Post-market trending reports
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Medical Device Quality pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 820Quality Management System Regulation (QMSR) — 21 CFR Part 820FDA · last revised 2026-02-02
- ISO 13485:2016Medical Devices — Quality Management Systems — Requirements for Regulatory PurposesISO · last revised 2016-03-01
- ISO 14971:2019Medical Devices — Application of Risk Management to Medical DevicesISO · last revised 2019-12-01
- IEC 62304:2006+A1:2015Medical Device Software — Software Life Cycle ProcessesIEC · last revised 2015-06-01