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May the 4th be with you!!

May 04, 2020

Last week I was able to rent and watch “Star Wars: The Rise of Skywalker” and take the edge off the ongoing social distancing in our household. If you haven’t seen it (I won’t share any spoilers) it finishes the series off nicely. But it reminded me of the common response when I moved from a Technical role within an IVD industry to my first Regulatory position many years ago…

Oh NO!! You’ve joined the DARK SIDE (Queue dramatic music here!)

The initial move was actually quite a challenging move and I really struggled to change my perspective from being on the other side of the RA line. From a busy lab environment to the quiet office work of Regulatory Affairs, it was a very different type of work and a different series of deliverables, but certainly no less challenging. Very early on I realised that the more you read, and having a thirst for knowledge, the more you develop an understanding of the IVD regulations. The diversity of the day to day challenges was immense, from global trade compliance, product registrations, packaging, animal origin certification, design changes to risk management - I had to cover so much ground throughout the organisation I was working for at the time. It took many months to get a full handle of the roles and responsibilities from the day to day function of a RA professional.

At first it felt like a different world to my old technical roles. But actually, the knowledge and experience that I had developed from manufacturing and technical functions really provided a solid grounding for the new RA role. My technical understanding of the products, and the method of manufacturing was so important to assess the state of the technical submission files and design changes that I would be reviewing as RA. Without this experience I would not been so effective in my role. In addition, I had a good understanding of a non-RA perspective when compliance issues came up. Half the battle of RA is to be able to clearly and objectively relay the key regulatory requirements and expectations in a way that the other person can understand and appreciate. Can you get the key information across in 5 minutes before they just switch off as its “just RA stuff!”.

So all my working life, from jobs in pie factories (for 3 days), warehouses, tourist ferries, sport centres and then IVD companies, has resulted in me turning to the dark side. So on this day I would like to think that in turning into the Regulatory Affairs professional I am , I’ve also been able to bring some of my Jedi skills with me too…. Stay safe in the this period of continued Covid-19 lockdown and above all… May the 4th be with you!!

Me donning my Sith cloak (fleecy dressing gown in these self-iso conditions). 😊

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