Ashleigh Batchen

Ashleigh Batchen

Regulatory Strategy Principal (UK) (Medical and Health Services UK & Global)

Tell us about yourself

My undergraduate degree was in Genetics from the University of Aberdeen and I hold a postgraduate qualification in Regulatory Affairs (Medical Devices) from TOPRA. After graduating, I initially found myself in the recruitment space where I was recruiting for pharmaceutical and medical device roles, including regulatory professionals. From that experience, I ventured into the regulatory world myself, joining the Medicines & Healthcare products Regulatory Agency (MHRA) where I held roles in post-market surveillance, policy and market surveillance. Most recently before joining TÜV SÜD, I was Head of Regulatory Affairs at BIVDA, responsible for supporting member organisations with regulatory support and representing the IVD industry. I joined TÜV SÜD in September 2023 as Regulatory Strategy Principal (UK) in Medical and Health Services UK & Global.

Why did you choose to join TÜV SÜD?

I have been fortunate to work with the UK Regulator and in industry through my role in a trade association. I was keen to expand my experience to include a Notified Body/Approved Body and TÜV SÜD was a perfect fit for me!

Where do you work?

I primarily work from home – it’s common to see one of my two cats walk across my desk during Teams calls!

What are your main areas of expertise?

I have worked across a range of medical devices, but my main experience has been with in-vitro diagnostic devices (IVDs) and medical devices commonly used in the cosmetic sector. My focus is on UK and EU Regulations, including the evolution of new policy.

What does your role involve?

My role sits in the UK division of MHS as well as in the Global Regulatory Strategy team. I am responsible for supporting the UK Approved Body where required, either externally or providing expertise and input internally. Within the Regulatory Strategy Team, my role is to act as a liaison between the EU and the UK, and represent the Notified Body with stakeholders.

What most interests you about your role?

The UK Approved Body is currently going through expansion of scope to include IVDs. I’m really excited to be involved in this work and utilise my IVD experience to support the team as much as I can. The UK is developing new regulations for medical devices and IVDs which means no day is ever the same as we navigate the changing environment – it keeps us on our toes!

What exciting developments have you seen at TÜV SÜD since you started?

TÜV SÜD has been working closely with the other UK Approved Bodies to establish Team-AB, a single entity that brings the Bodies closer and acts as a liaison for stakeholders. This is a hugely positive step in working together to create consensus documents and guidance, as well as to share our expertise. We’re incredibly proud that TÜV SÜD is Co-President of Team-AB!

What future trends do you see developing in your area of work?

The world is becoming a much more digital place and this is reflected in the medical device space. Software, AI and machine learning will be the future, and we need to be adaptable to this adaptation.

What is your biggest challenge?

Although the changing regulatory environment introduces many opportunities, it is moving very rapidly which can be challenging to stay on top of. Luckily, we have a great team of people working together to manage this.

What do you see as the top perk of working for TÜV SÜD?

TÜV SÜD is a very flexible place to work, which I hugely appreciate! I feel very trusted in my role and have fantastic teams around me who are always incredibly supportive and friendly.

How have TÜV SÜD supported you?

Everyone is very welcoming and more than happy to take time out of their day to help with anything they can. Given the size of the organisation, it can be a bit daunting sometimes to know who to go to, but it’s always received in such a positive way!

Describe your fellow workers in five words

Responsible, adaptable, supportive, knowledgeable, committed.

What advice would you give to anyone thinking of applying for a role similar to yours?

Take the leap of faith! Regardless of the role you end up in within TÜV SÜD, there are so many opportunities and ways to learn.

ADDITIONAL INFO

Papers, research, work published in industry publications, patents, etc.

“The future of in-house test requirements in the EU and the UK”

Journal of Medical Device Regulation, Volume 20, Issue 3, 2023)

In Vivo’s 2023 Rising Leaders: Healthcare Innovators at the Top of their Game

Listed on In Vivo’s 2023 Rising Leaders: Healthcare Innovators at the Top of their Game

“At the Forefront of Regulatory Change”

In Vivo, 2023

committees

• Innovate UK KTN Global Expert Mission, Taiwan (From Jan 2024)
• Team NB/NBCG representation (From Nov 2023)
• Team AB Working Groups, various (From Nov 2023)
• TOPRA MedTech SPIN Group (From May 2023)
• TOPRA Symposium Steering Committee, IVD (From Nov 2022)

INDUSTRY PRESENTATIONS

TOPRA Symposium (Co-Chair of IVD stream) - 25 October 2023

TOPRA Essentials of IVD Regulation module (Chair) - 5 July 2023

Medtech Summit, UK regulations, procurement - 22 June 2023

Medtech Summit (Chair of IVD stream) - 23 June 2023

Roadmap to Compliance - Bench to Bedside, panel member, regulatory changes in the UK and EU - 22 March 2023

Related Services:

Medical Device Regulation

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