Welcome to the first edition of Vakula Connect, our quarterly read on the US pharma, medical device and regulated IT market, written for the consultants who work in it and the clients who hire them. Each edition covers what moved, what it signals, who is in demand, and what is new at Vakula Technologies Inc.
The storyline of 2026 so far is that the work has shifted from writing new rules to living with them. Three major frameworks are now in force at once, and the organisations doing well are the ones that can show an inspector how a risk-based decision was made, not just that a document exists.
Regulators: three frameworks, one expectation
FDA's Quality Management System Regulation has been in effect since 2 February, aligning device quality systems with ISO 13485:2016; early inspections follow the ISO clause order and probe management review inputs, complaint handling and supplier controls. ICH E6(R3) has applied in the EU since July 2025 and is shaping US monitoring plans through sponsor SOPs. FDA's Computer Software Assurance guidance, finalised in 2025, has become the default model for new validation packages. The common thread is proportionality with a documented rationale.
Policy: immigration and engagement models
The H-1B modernisation rule, effective January 2025, has settled into practice: beneficiary-centric selection, closer attention to third-party placements, and site visits taken seriously. At the same time, more client master service agreements restrict corp-to-corp engagement, making W2 contract the default for most placements. Both trends reward staffing partners that keep a complete file on every engagement.
Delivery: distributed trials and distributed manufacturing
Hybrid and decentralised trial elements are now routine under FDA's 2024 guidance, and manufacturing networks have grown more distributed. In both cases the operational question is the same: who is accountable for oversight of remote activities and vendors, and how is that accountability evidenced during an audit?
Signal to leaders
Capacity is not the constraint; defensible judgement is. Hire and contract for people who can write the rationale, and hold vendors to the same standard.
In-demand talent, Q3 2026
- Validation and CSV engineers who can build CSA-style packages
- CQV and commissioning engineers for manufacturing expansion
- Quality engineers and internal auditors for QMSR-era inspections
- CRAs and study managers with risk-based and centralised monitoring experience
- Technical writers for validation and regulatory documentation
- Data engineers and test engineers inside GxP environments
Roles open now
Our job board lists several hundred live requisitions across the United States. Titles this quarter include Validation Engineer, Validation Specialist, Technical Writer (validation documentation), CIP Engineer, Senior Project Engineer, Clinical Research Associate, Regulatory Affairs Specialist and Drug Safety Associate. Search by title and location on the careers page.
At Vakula
- This website was relaunched in August 2026 with full service descriptions, a live job board, working enquiry and resume forms and this blog.
- Vakula Technologies Inc was incorporated in November 2021; the Q4 edition will mark five years.
- Consultant commitments restated: rate, duration, location and client disclosed before interview; feedback after every submission; no fees to candidates at any stage.
Join the conversation
What are you working through: QMSR inspections, E6(R3) monitoring plans, CSA adoption, engagement model changes? Tell us at info@vakulatech.com and we may feature the question in a future edition. Looking to hire or to make your next move? Reach out or send your resume.