Verification & Validation (V&V) Manager

Calla Lily Clinical Care Ltd is a women’s health B Corp developing Callavid® – a new patented vaginal drug delivery device to overcome the shortcomings of current methods. We aim to improve the clinical benefits and convenience offered by vaginal drug delivery systems with an initial primary focus on delivery of progesterone for miscarriage prevention and luteal phase support during IVF.  Our technology is starting clinical trials in 2025, funded by the UK’s NIHR.

 

Title: Verification & Validation (V&V) Manager

Contract: 12 months, full-time (min 40 hours/week)

Location: 2-3 days per week in-person in our London NW3 HQ

 

The Role:

The role involves overseeing the completion of design outputs (technical drawings, specifications) for our Callavid® device and ensuring labeling and packaging comply with medical device regulations. Leading design reviews and verification testing, the position requires developing protocols, coordinating testing, analysing data, and preparing reports, while ensuring traceability to requirements. Additionally, the role manages design validation, including our clinical trials, by liaising with CROs and maintaining documentation. Responsibilities also include maintaining the Design History File (DHF) and Device Master Record (DMR) per 21 CFR Part 820, managing product change control, and compiling the Technical File for UK, EU, and US regulatory compliance— ensuring the device meets all standards throughout its development lifecycle.

 

What you’ll do:

• Oversight of completion of design outputs, including technical drawings, product and component specifications for our Callavid® device and other products.
• Oversight of completion of labelling and packaging design in alignment with the relevant medical device and pharma labelling standards and regulations
• Lead the design reviews for Callavid, ensuring the product design is evaluated against requirements detailed within the TRS and URS
• Lead the design verification testing of the Callavid device and associated labelling and packaging.
  • Coordinate the supply of raw materials for the manufacture of DV samples
  • Ensure test methods are documented, validated and staff are trained (training is recorded)
  • Develop the design verification protocol, including traceability to the TRS and test reports
  • Coordinate internal and external testing in accordance with the protocol
  • Analyse test data and prepare a design verification report
• To lead the design validation of the Callavid device, including Clinical trials
  • As above for design verification, plus:
  • Liaison with CROs, including the coordination of all documentation and evidence required for clinical trials
• Maintain the design history file in accordance with 21 CFR part 820 requirements
• Manage product change control, in accordance with the relevant CLCC procedures
• Maintain the Device Master Record in accordance with 21 CFR part 820 requirements
• Regulatory:
  • Collate the Technical File in accordance with the relevant regulations (initially UK, EU and / or US)

 

Who you are

• Ensures compliance with medical device regulations (FDA, EU MDR)
• Drives product development from design to verification/validation
• Coordinates cross-functional teams (engineering, regulatory, clinical)
• Maintains critical documentation for audits and submissions
• Has a passion for women’s health, with a strong desire to apply your unique perspective, experience and talents in a fast-paced start-up environment
• Action-oriented: time is our scarcest asset – we need to balance planning versus execution
• A catalyst for change: we like individuals who question assumptions and can improve how we operate

How to apply

Please send your CV/resume and brief cover note to both akhan@callali.ly and jointheteam@callali.ly