Q&A with Darren Mansell, Regulatory Affairs Manager
We spoke with Darren Mansell, our Regulatory Affairs Manager. Darren has been with us for over 14 years and plays a key role in making sure our products comply with regulations. It’s been amazing to see Darren and his team tackle the new challenges we’ve faced during the pandemic.
What does your role entail?
A big part of my job is making sure our products comply with regulatory requirements so we can sell and operate in markets around the world. We always look ahead to make sure we’re up to date and ready for any new regulations or changes that might come.
With Brexit and the Medical Device Regulation 2017/745 (MDR) now in effect, it’s a very busy time in Regulatory Affairs. We’re working as a cross-functional team with colleagues in Operations, R&D, and our sales teams to deliver both new and established drug delivery and diagnostic products to our customers.
As regulations change, we’re reviewing and rethinking our processes in Regulatory Affairs to make sure we stay compliant and work as efficiently as possible for both our internal and external customers.
How are you supporting our customers during this pandemic?
Meeting compliance standards and supporting customers while working remotely has been a challenge, but the Regulatory Affairs team has handled it well. During the pandemic, we supported a remote Notified Body surveillance audit, multiple registrations for medical devices, and responded to regulatory questions from customers about new products like our safety syringes.
What excites you most about the future for Owen Mumford Pharmaceutical Services?
With new regulations and product innovation, it’s a challenging and exciting time to be at Owen Mumford. Some new products mean we’re growing our presence in new markets or building strategies to meet updated requirements in places where we already operate. This allows Regulatory Affairs and the Pharmaceutical Services team to display our expertise as a global leader in drug delivery solutions.