And i interviewed last week with a midsize device company and learned RA reports to Sales and “evidence” is handled ad hoc — both felt risky from a compliance standpoint. What questions or signals do you rely on to verify they support lawful, ethical submissions and robust post-market vigilance (FDA/EMA) before signing an offer?
I covered my PS by pairing Betty Colonomos’s Bilingual Mediation with CATIE Center’s Deaf Interpreting modules; both lean into cultural mediation and tightened my pre-briefs with hearing partners. > K–12 welcome). Personal experiences with a specific instructor or program would help me choose. For K–12, Colonomos’s work translated cleanly to IEPs, and CATIE’s modules are here: https://catiecenter.org/deaf-interpreting/ — spots fill fast; want me to DM upcoming dates?
Quick test I use: ask to speak with the ISO 13485 management rep/PRRC and request their last “PMS trend/CAPA board minutes,” plus who has authority to stop a release — if it’s Sales, that’s the fox writing the SOPs. Also ask, “Who drafts and signs MDRs/483 responses, and how often do you review signal detection metrics?” In tiny startups a Sales reporting line can be survivable if QA/RA has documented veto power and direct access to the CEO.
Ask to walk through one anonymized vigilance case end-to-end — complaint intake to MDR/MIR — showing timestamps, approvers, and who owned the clock; if Sales edits the narrative or sign-off, I walk. @loganw_04 is right that a Sales reporting line can work, but I still want the last late-case RCA and CAPA on-hand — will they show it?