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Edwin Lindsay

Principal Consultant/Managing Director - Compliance Solutions (Life Sciences) Ltd


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Principal Consultant – Compliance Solutions( Life sciences) Ltd

Edwin is a Micro/Molecular Biologist with extensive experience working in the Life Sciences and Medical Devices/IVD Industry for over 20 years and has proven expertise in regulatory affairs, clinical, quality, and validation, and has recently been a member of the UK Trade and Investment Healthcare Advisory Group consulting the UK government on healthcare issues and export.

Edwin’s extensive quality, validation, and regulatory experience has encompassed roles at Smith and Nephew, Ethicon, AorTech Europe, MI Services (Consultancy), and Omega Critical Care.

Edwin also has extensive experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, and Japanese PMDA. Edwin has extensive success in regulatory strategy development and execution, including multiple US FDA 510(k) clearances and IDE and PMA approvals, as well as, CE Mark Technical File and Design Dossier approvals.

These roles involved the preparation of new and amended European (CE Marking) and US FDA Regulatory (510K, PMA, IDE, Presub’ s) submissions, development and implementation of quality systems to ISO 9001, ISO 13485, and the US FDA Quality system regulations, relocation of manufacturing processes to new manufacturing facilities and for the purposes of sub-contracting. Edwin also worked with the Scottish National Blood Transfusion Service setting up the Scottish Cord Blood Bank and a series of stem cell banks throughout the service.

Edwin is currently Principal Consultant at Compliance Solutions working with many clients including Scottish National Blood Transfusion Service, EnteroBiotix, QSpine, Current Health, Abbott, Neurovalens, Teleflex, Gyrogear, Axis Spine, Vascular Flow Technologies, Kimal, Brightwake. He has worked with all classes of devices from active to implantable, including custom devices, electronics, and software/artificial Intelligence

Edwin also currently lectures at the University of Strathclyde and Glasgow University on medical device regulations

Edwin also works with the EU Commission’s Horizon 2020 Funding Programme as a coach assisting companies with quality and regulatory advice.

Edwin Lindsay

We work with more than 200 leading Life Sciences companies including:

Working with Life Science Access Academy, our company love the variety of the many courses that are on offer. The hour long courses on specific subjects are really useful on Friday lunchtimes for our field teams and gain a lot of interest.

Life Science Access Academy are also super flexible and helpful when it comes to tailoring some additional sessions to our needs.

Marsha Gray, Training Specialist

Boehringer Ingelheim Ltd

We have been partnered with LSAA for several years now which has enabled our team members to develop their competencies and capabilities.

With over 700 learning modules, regular webinars on highly relevant topics across the UK, the opportunity to engage with expert speakers after events and regular blogs and newsletters, the platform is a highly valued resource at Ferring.

The team also provides regular usage statistics so we can understand the hot topics in Ferring and enable colleagues to share knowledge and experience with each other.

Paul Runeckles, Director of Execution Excellence

Ferring

Frontier Medical has fully implemented, Life Science Access Academy allowing Sales and Marketing to utilise the system. Maximising on line learning for all remote staff stimulates a culture of self-development giving individuals the accountability and responsibility to broaden their skills set.

Life Science Access Academy training is topical and a good fit for the faced paced healthcare market.

Simon Warden, National Sales Manager

Frontier Medical Group

I have found the training via the Life Science Access Academy to be excellent and I know many of my colleagues have as well.

The content is always kept up to date and there is huge and interesting variety of topics covered. The site is curated in a way that makes it clear and easy to navigate. Also, the staff at Life Science access Academy are friendly and responsive and all the experts are always knowledgeable in their areas.

Richard Edmonds

Gedeon Richter Women's Health

The variety and relevancy of content brings value to many different roles across the healthcare industry.

I have also been overwhelmed by the way the Life Science Access Academy team have accommodated our own business needs, being sensitive yet responsive to helping us since its formation.

Robb Sayers, UK Capability Lead

ViiV Healthcare