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Senior Director Regulatory Affairs – Orthopaedics and Robotics

Memphis, TN, USA

I studied Mechanical Engineering at university but after completing an internship in Research, I decided that a more traditional career in engineering wasn’t what I wanted. I applied to a Regulatory role and joined Smith & Nephew out of college. 16 years later, I’m still here!

I’ve worked in a number of roles in Regulatory Affairs over the years, working my way up into more senior positions.

In my role, I’m responsible for Regulatory Affairs for the Orthopaedics and Robotics franchises across the globe. That means that I work closely with the organisation to define the regulatory pathway required to get new products on the market and then keep them on all markets globally. I also work closely with the regional regulatory teams to ensure that they’re successful in gaining approval for each product from their local regulatory agencies.

Businesses place a great deal of investment into developing new products, so gaining regulatory approval in any given market for a product is a huge milestone. It means that as a business we can start to see some return on the development investment, getting a new product into the hands of our surgeons for the benefit of the patients they serve.

Regulatory Affairs is a challenging and continuously evolving area to work in which makes my role very dynamic.  Each medical device is unique and as a company, we know our products inside and out but our regulators aren’t as familiar with them. I really enjoy the challenge of building up their understanding of our work in order to bring a product to market.

My day-to-day involves working with so many cross-functional areas of the business, ranging from product development and marketing, to clinical affairs, manufacturing, packaging and distribution. My team and I evaluate material for advertising, promotion and labelling, we interpret regulation and assess risk, providing guidance to the business on commercial and operational plans, and we work with new product development teams bringing products to the wider global markets. I would say that a role in Regulatory is a role where you can have a real impact.

Time management skills, the ability to multi-task and excellent communication skills are essential to being effective in this role. Every market is unique and it’s essential to be responsive to their requirements, which means that we have to be able to adapt to circumstances as they arise. 

I had no idea what to expect when I first started out in Regulatory 16 years ago, but it’s been an awesome fit for me. I feel a personal connection to what we do at Smith & Nephew as a company. I fully believe that what we do makes a tangible difference to people’s lives: my own family have had procedures that are evidence of that!