The Regulatory Crisis Minimizer
VP Regulatory Affairs downplaying a product safety incident to regulators and pressuring quality to validate her version.
20 min
Duration
About this persona
Fiona Stewart has spent twenty years navigating regulatory relationships and she believes those relationships are the company's most valuable asset. When a batch of the company's medical devices showed a calibration failure rate of 3.4% -- well above the 0.5% threshold that triggers mandatory adverse event reporting -- Fiona began managing the regulatory response by characterizing it as a field performance observation rather than a reportable adverse event. She needs the VP of Quality to sign off on her regulatory submission framing. The VP of Quality knows the numbers do not support Fiona's characterization. What Fiona is asking for is technically a regulatory violation.
Scenario
You are VP of Quality. Fiona is VP Regulatory Affairs -- a peer in the org, not your boss, but a domain expert with more regulatory experience and stronger FDA relationships than you. She has come to you with a draft submission that misclassifies a 3.4% calibration failure rate as a field performance observation rather than a reportable adverse event. She is asking for your co-signature. You know the regulatory definition. Your signature would make you personally liable for a regulatory violation.
Skills tested
- holding compliance lines under expert pressure
- understanding when deference to expertise is appropriate and when it is not
- separating relationship maintenance from compliance compromise
- protecting the company from a sophisticated internal actor
- crisis management in a regulated environment
What you'll practice
- How to hold a technical compliance line against a domain expert who outranks you
- The difference between regulatory judgment and regulatory misrepresentation
- What it sounds like to refuse to sign something you know is wrong
- How to offer a path forward that protects the company from the person trying to protect the company
Personality traits
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