BF regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
Senior Regulatory Affairs Manager for HealthTech and MedTech companies.
As a process F 29/100 · Will not run — References files that are not bundled: ../mdr-745-specialist/, ../fda-consultant-specialist/, ../quality-manager-qms-iso13485/
How to improve
- The text references files that are not there: add them or drop the references.
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 0
✓ No critical or high findings
Files scanned: 7. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
missing-refreference to a missing file: ../mdr-745-specialist/ - warning
missing-refreference to a missing file: ../fda-consultant-specialist/ - warning
missing-refreference to a missing file: ../quality-manager-qms-iso13485/ - warning
missing-refreference to a missing file: ../risk-management-specialist/ - note
frontmatter-keyunknown frontmatter key "triggers"
Process rating: all ten parameters 29/100
- 0Tools and files. 4 referenced file(s) missing: ../mdr-745-specialist/, ../fda-consultant-specialist/, ../quality-manager-qms-iso13485/
- 0Result and completion. Does not say what the result is
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 0Progress reporting. Says nothing while it works
- 20When it triggers. No condition that starts the skill
- 30Running it twice. 1 mutating operations with no state check
- 70Execution cost. Instruction body is 4624 tokens
- 85Steps. 122 steps, 1 vague phrases
- 100Consistency. Name and required fields are in place
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- -31 of 2 scripts are never mentioned in SKILL.md
- +1No license
- +2Single-language instructions
- +3Description length 768: enough signal without eating the budget
- +4Structure: 34 headings
- +3Step-by-step instructions: 122 items
- +4Has examples (5 code blocks)
- +4Reference files are cited in the instructions (4 of 4)
Quality base 70; lint remarks subtract, signals add up to 100. Result: 72.