Regulatory affairs or quality specialist · Core track · The file that stands up
Take a device through its rules: classification, the technical file, risk management, vigilance and recalls, with the evidence an auditor asks for.
For: Regulatory affairs and quality staff at manufacturers, distributors and regulatory teams.
The arc · 10 weeks · The file that stands up
What you'll be able to do
The story
You join the regulatory affairs and quality team of Halcyon Medical (fictional), a Medical City company that designs a few devices and distributes many, including to Medical City Hospital. Your product for ten weeks is the home haemodialysis needle-dislodgement monitor from the Design Studio project 'Asleep on the Machine': you take it from intended purpose to its first complaint, while the distribution side and the hospital's quality team live with the same rules from the other side of the counter.
“Classification follows the intended purpose, not the hardware. Write the purpose first, in the words the labelling will use, and every class, pathway and test plan follows from it.”
Inside the track
The real screens: My track, a step with your mentor, a simulation, your skills map and the certificate.
The arc
Each week is one working shift: learn, see inside, do, work, think, check, reflect. Open a week to see its real steps.
Gate by gate
The needle-dislodgement monitor: no class, no pathway, three markets in the sales plan.
You make: Intended purpose and classification memo
Halcyon's QMS before the surveillance audit: forty suppliers, three that matter most.
You make: Internal audit record: supplier control
The monitor's risk file, rebuilt around the failure that kills: a missed dislodgement.
You make: Risk analysis table for the five most serious hazards
Firmware that decides, a sleepy user, and a proposed app that relays alarms.
You make: Software classification and usability engineering plan
A traceability matrix with gaps, and a label that claims more than the tests showed.
You make: Design verification protocol: detection function
Three markets, three queues, one technical file that has to serve all of them.
You make: Regulatory strategy for three markets
The goods-in door: donated monitors, suspicious probes, and a registration question from the Gulf.
You make: Incoming inspection record with quarantine decision
One quiet monitor, one ventilator notice, one death under investigation.
You make: Complaint investigation and reportability decision
An auditor in the building, a notice in every ward, and pumps nobody can find.
You make: CAPA summary for the auditor
The monitor's file, handed to the auditor.
You make: Capstone presentation and sign-off
Proof
A step is done when there is evidence: a simulation score, a saved work document, a passed check or a signed observation. Opening a page never ticks anything.
The certificate
It names the track and the level you completed. Your portfolio holds the work behind it.
For the needle-dislodgement monitor (or one of your organisation's devices), produce the core of the technical documentation: intended purpose and classification with rules, the risk analysis with controls and their verification, the software and usability plan, the verification protocol and traceability, and the labelling claims each traced to evidence.
Evidence it gives: The documents a notified body or FDA reviewer samples first.
For one device, a defended regulatory strategy for three markets: the US pathway with predicate rationale or De Novo case, the EU conformity route, a third market's registration route verified at its regulator's own sources, labelling and UDI, the market sequence and dates with stated assumptions.
Evidence it gives: A documented, sourced pathway decision for management review.
Write a post-market surveillance plan for one device and run one real or simulation-based complaint through it end to end: record, reportability decision on the clock, investigation, CAPA with an effectiveness check, field action decision, and the update to the risk file.
Evidence it gives: A vigilance and PMS record of the kind regulators sample.
Three levels
A baseline check on day one places you, or you choose. The competencies are the same at every level; the support and the pressure change.
Baseline under 50%, or chosen · simulations at Foundation
For people new to regulatory and quality work: worked examples first, guided simulations at Foundation with the coach on, the extra and Hard-only cases hidden.
Baseline 50% to 74%, or chosen · simulations at Practitioner
The standard track for engineers moving into regulatory and quality roles: Practitioner difficulty, the SaMD, inspection, air-in-line, alarm change, OTC, counterfeit and notice cases added.
Baseline 75% and above, or chosen · simulations at Expert
For practising specialists: Expert difficulty, every case, strict thresholds and a timed boss week.
Ways to get this track
Complete track
$449for 12 months
General Essentia, the Studios and Design are not included. Subscribe within 30 days and what you paid counts toward your plan.
Premium · Pro
$299a year with Premium
Organisation licence
Branches
Each branch keeps the core track's shape and focuses on one area of work. Each is sold on its own as a Deep Dive, and all of them come in the Full family.
Branch · Regulatory & Quality Specialist
In six weeks a regulatory specialist can classify a device in the US system, build a 510(k) equivalence argument, judge when De Novo or PMA fits, outline a device study, and decide changes after clearance with documented reasoning, all taught from real models' public FDA records.
Certificate of Completion: Regulatory & Quality Specialist, FDA Submissions branch
Branch · Regulatory & Quality Specialist
In six weeks a regulatory specialist can classify under the MDR with a rule-by-rule rationale, build a GSPR evidence map and technical documentation, prepare for a notified body, plan clinical evaluation to match claims, and run post-market surveillance and vigilance.
Certificate of Completion: Regulatory & Quality Specialist, EU MDR branch
Branch · Regulatory & Quality Specialist
In six weeks a regulatory specialist can map the GCC regulators, build a sourced registration plan and dossier index from existing evidence, allocate duties in distribution agreements, control import and storage in a hot climate, and run post-market duties across several markets, citing every country-specific requirement to the regulator's own current publication.
Certificate of Completion: Regulatory & Quality Specialist, Gulf Registration branch
Branch · Regulatory & Quality Specialist
In six weeks a quality or vigilance professional can recognise and triage complaints, investigate without destroying evidence, trend and close CAPA on effectiveness, and run field safety corrective actions to closure, from the manufacturer's, the distributor's or the hospital's side.
Certificate of Completion: Regulatory & Quality Specialist, Post-Market branch
FAQ
Anything else, write to the team and we answer directly.
Yes. An organisation's licence includes every track, core and branch, with the Platform, Medical City, Essentia, the App and the dashboard. Your organisation enrols you on the track, and it appears under My track; there is nothing extra to buy.