I am a consultant specialising in complex medical devices, biotechnology, IoT-enabled healthtech and general consumer products. With a proven track record in regulatory compliance, global manufacturing scale-up, and end-to-end supply chain strategy, I help innovative companies navigate FDA, CE, ISO, and GMP requirements while optimising cost, efficiency, market readiness, project delivery and new product introduction.

My 25 years expertise spans over 50 early-stage startups to established SMEs and manufacturers, delivering product approvals, operational excellence, and risk-managed launches worldwide. I am a contracted startup mentor for TechScaler (Codebase) and Barclays Eagle Labs.

Where I can help you

Supply Chain Management

Manufacturing (including low cost countries), Logistics and shipping, kitting and distribution, procurement, strategic sourcing & cost down, end-to-end value stream analysis, Lean / 6 Sigma methodologies, high risk component sourcing.  Contract writing and negotiation. New product introduction. 

Regulatory Compliance

Product conformity, CE and FCC conformity, audit, technical file compilation, declaration of conformity. FDA 21 CFR Part 11, EU GMP approval and certification. Technology transfer from design to production, validation and implementation. Software/process and manufacturing validation.

Quality Management System

ISO 13485 system writing, training, implementation and certification, ISO 9001 writing, training, implementation and certification, ISO 14001 Risk Management implementation.  Full SOP, forms and quality manual creation and training.  Supplier development and relationship management. 

Business Systems and Projects

Fully integrated Enterprise Resource Planning (ERP) assessment, evaluation, implementation and validation.  Product shipping and logistics. CRM and product lifecycle management systems. Project management and problem solving. Software implementation and validation.

How I can help you to get investment

I have helped several UK companies raise over £30M investment from pre-seed through to series A.  I can help to write or refine pitch decks and business cases, source potential investor candidates (angel > VC) and I can support pitch readiness or in some cases join your pitch process. I have made over 100 investor pitches either as a consultant or in a fractal support role.

A successful track record means I can help you  - right first time

Some short examples of my experience and key achievements.

Calcivis Biologics

  • Developed, implemented and achieved FDA approval of electronics manufacturing in China.
  • Developed, scaled and achieved FDA approval of cGMP biologics manufacturing in Spain.
  • Developed, scaled and achieved FDA approval for product kitting and order fulfilment.
  • Achieved ISO 13485 certification and FDA PMA approval.
  • Validated cold-chain global logistics capability.
  • 35% manufacturing production cost down.
  • Implemented customer order B2B fulfilment to the US/EU.
  • Implemented and validated ERP software.
  • Former worldwide VP Operations.

Aquarate IoT Remote Monitoring

  • Mentored the design engineering team (hardware/software) through DFM and product approvals (CE/UKCA).
  • Developed, implemented, and validated subcontract manufacturing in Lithuania.
  • Implemented kit-to-order and fulfilment process and eCommerce platform.
  • Implemented customer order processes and product logistics and fulfilment to +100 care homes in the UK.
  • ERP implementation and validation.
  • Former Operations Director and board member.

Eclateral IVD Test Strip and Device

  • Developed the regulatory approval and production strategy for a COVID-19 invitro diagnostic test system including test strip, IoT reader and custom application software.
  • Manufacturing transfer, validation, and scale (hardware and application software combination).
  • Wrote full ISO 13485 quality management system, implemented, and passed UL stage I audit.
  • ERP implementation and validation.

ISO Tracker SaaS

  • Developed risk management plan and software validation protocols and test scrips.
  • Completed software validation to comply the US FDA 21 CFR and EU GMP regulatory frameworks.
  • Met client lead time and budget to release product.
  • Full protocol, test scripts and final report documentation pack created for 8 modules.

Alere Tech (IVD)

  • Global supply chain development to support product launch.
  • Global clinical trial logistics and supply.
  • Cold chain validation and global shipping capability.
  • Kitting process implementation and validation.
  • End-to-end customer order logistics and order fulfilment.

Valneva Vaccines

  • Setup a supply chain for GMP biologics compliance achieving FDA Biologics License Approval approval.
  • Setup and validated 3rd party fill-finish contract manufacturing.
  • Developed implemented and validated global cold chain logistics to supply the market
  • Setup 'surge and sustain' vaccine cold-chain for the US military deployment.

Boundary IoT

  • Project managed the complex hardware/software technology transfer from design to production.
  • Selected, validated and scaled full-service manufacturing in China.
  • Developed and implemented product inventory control, kitting, and order fulfilment to end users (direct B2C eCommerce process).
  • Achieved ISO 9001 certification.
  • ERP implementation and validation.

Inflow ADHD SaaS

  • Audit of all marketing materials (print, socials) and the assessment of software as a medical device (SaMD) classification.
  • Assessment against the regulation and evaluation of NHS digital mental health technology (DMHT)
  • Wrote the indented use of the product is a self-help guide (for ADHD) and not a medical device.
  • Wrote marketing claims standard operating procedure to ensure compliance to non-medical device classification.

Robotical Robot

  • Engineering cost down – product tear down and cost reduction opportunities identified.
  • High-risk components sourced to avoid launch delay.
  • BoM risk assessment to derisk production schedule and control cost of goods.
  • New product manufacturing evaluation, transfer plan and regulatory approval strategy developed via a global tender process.

IntelliDigest Robot

  • Developed ISO 9001 quality management system.
  • Developed investment strategy and pitch deck / business case.
  • Developed contract manufacturing and supply chain.
  • Developed end-to-end bio nutrient logistics network – from waste food to farm.
  • Fractional Operations Director.

XSITU IoT

  • Regulatory strategy.
  • Business plan and budgeting process.
  • Manufacturing strategy and sub contract production in Poland.
  • Pitch deck and investment strategy.
  • Quality management system.
  • Hardware and software validation.
  • Fractional COO.

Voxblock

  • Regulatory risk assessment
  • Technical file compilation
  • Team training on quality management and supply chain resilience.
  • Audited product declaration of conformity assessment and created conformity statement.
  • Developed investment strategy and investor pitch deck.

Testimonials

Robin Knox - Exited Founder/NED/Executive in Residence

"Steven played a pivot role in the launch of Boundary - key in setting up the supply chain, contract manufacturing,  installing and operating QMS as well as problem solving on the fly to ensure the product reached our customers. I wouldn't hesitate to recommend his wide range of skills, dedication and team spirt"

Dominika Piekutowsha-Swed - Founder / CEO XSITU

 " Working with Steven has helped us to formulate our startup and develop a clear strategy both in terms of organisation and becoming investor ready.  He has helped us build our business plan and investment pitch process - we would not have been able to accelerate our business without him "

Jonny Marchbank - Product Design Manager Aquarate

 " I cannot recommend Steven highly enough if your seeking some to help navigate regulatory and manufacturing supply chain.  As well as being well connected and knowledgeable, he is extremely trustworthy and holds a lot of integrity, which is hard to come by in an industry where a lot can go wrong"

Jackie Fleming - Operations Director Alere

"Very strategic in terms of supply chain and gets into the tactical when needed.  Keen to continue learning and was always giving in terms of his help and support.  Steve adapts to situations and never let us me down" 

 

Apurva Goswamy - CEO CONTINUUM India LLP

"Steve demonstrates great initiative, a uniquely creative approach and demonstrated vision.  He radically turned our performance around, the entire approach changed from reactive to proactive. Steve is a person you want in your camp and if I had the opportunity to work with him again I would do it in a heartbeat.

 

Working with me is easy!

Flexible engagement. Rapid delivery. Proven execution across complex regulated technology environments.

I offer a flexible engagement model designed to support organisations at different stages of growth, from early-stage startups to established companies. My approach is pragmatic, delivery-focused, and adaptable to your operational needs.

Engagement Models

  • Fractional support – ongoing strategic and operational support on a part-time basis.

  • Interim roles – hands-on leadership during periods of transition, scale-up, or change.

  • Project-based delivery – clearly defined workstreams with agreed scope, milestones, and outcomes.

Where appropriate, I can also offer fixed-fee or fixed-investment rates, providing cost certainty and transparency from the outset.

Working Arrangements

  • Fully remote

  • On-site

  • Hybrid

I am comfortable working independently or integrating seamlessly into existing teams, adapting to established processes and ways of working.

Delivery Approach

My focus is on rapid, high-quality delivery. I prioritise:

  • Clear definition of objectives and success criteria

  • Practical, proportionate solutions aligned to regulatory and commercial realities

  • Efficient execution to meet time, budget, and quality expectations

Whether leading a workstream end-to-end or supporting internal teams, I aim to accelerate progress, reduce risk, and deliver measurable outcomes.

Contact

07525 780822

Stevenvalentiemail@gmail.com

A bit about me

After graduating Newcastle Business school with a BA Hons degree in Supply Chain and Applied Logistics I joined the IBM procurement team.  After that I entered the fast-track graduate program at Motorola working in all areas of their operations including a six month assignment in Singapore as EMEA new product introduction project manager transferring mobile phone designs to production in the UK and Germany.  After Motorola I joined NYSE global eye healthcare care business Bausch and Lomb where I worked as global procurement manager for their commercial, corporate and marketing sector based in the New York HQ.  When B&L closed I joined Intercell Vaccines as head of supply chain and engineering where we developed and gained FDA approval for the world first FDA approved encephalitis vaccine.

After Intercell I joined Alere Technologies as supply chain manager in the cardiometabolic space where we launched the worlds first fingerstick assay for home monitoring of congestive heart failure.  Since then (2014) I have worked as a freelance consultant doing project work.  I have done senior fractional roles with Boundary (Director of Supply and Quality), Aquarate (Director of Supply Chain and Non-executive director) and Vice President of Calcivis where we became the first Scottish company to gain FDA pre-market approval for a biologics/electronics combination device in the dental sector, Global Category Manager at Diageo and COO of XSITU.  

I am a contracted startup mentor for Barclays Eagle Labs and Techscaler (Codebase) where I have mentored about 50 tech startups helping them build supply chain capability, quality systems, gain regulatory approval and gain funding from seed to series A.  Between 2019 and 2023 I studied economic game theory at Yale, Innovation and Growth at the Babson College and completed the Entrepreneurial Scot Innovation and Growth Catalyst program.  I am a chartered purchasing manager via the Chartered Institute of Purchasing and Supply.  I am a former PGA professional golfer with three PGA tournament wins.  Based in Falkirk Scotland I am married for 30 years with 5 children.