Vakula Connect, Q2 2024: The LDT rule and laboratory regulation

Our Q2 2024 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.

Vakula Connect, Q2 2024: The LDT rule and laboratory regulation

Vakula Connect is our regular update for consultants deciding where to take their next assignment and for clients planning their next programme. This edition covers Q2 2024.

Market signals

  • FDA finalised the laboratory developed test rule in May, and clinical laboratories started LDT inventories and quality system gap assessments.
  • Demand for regulatory consultants with IVD and laboratory experience rose quickly; the pool was small.
  • Clinical operations hiring was steady, with continued emphasis on risk-based monitoring experience.

Roles in demand this quarter

Titles that recurred in client requisitions: Regulatory Affairs Specialist (IVD/LDT), Laboratory Quality Manager, Biostatistician, AWS Engineer. Current openings are always on our careers page.

Signal to leaders

The disciplines that were hardest to fill were the ones where clients needed judgement as well as capacity; briefing for the judgement shortened time-to-fill.

At Vakula

We supported laboratories with regulatory and quality consultants for LDT readiness and added laboratory quality to the disciplines we recruit for.

For consultants

Rate, duration, location and client are disclosed before you decide to interview; you get feedback after every submission; there are no fees to candidates at any stage. Send your resume.

For clients

Send one requisition and judge the shortlist. Start here.

Join the conversation

Tell us what you are working through at info@vakulatech.com; we may feature the question in a future edition.

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