Listen to our latest episode in the ‘Health at Heart‘ podcast series featuring Dr David Steinhaus
“As we move further into the medical space, RAQAC is absolutely essential to B-Secur. We have a significant opportunity to carve out an untapped space in the market and to truly support customers and patients in the early screening and the subsequent understanding of those non-life threatening early cardiovascular, stress and life impacting events.
“The ability for a clinician and eventually a customer to be able to understand and act on an early warning sign would be truly paradigm shifting. We can only support this vision with a robust quality and regulatory infrastructure.”
Rebecca joined the company during a sustained period of expansion as our headcount more than doubled and a number of the new employees are members of Rebecca’s team.
She said: “I can truly say our HR leadership and executive team have been fantastic in supporting the onboarding of the new team. From recruitment through to the initial three-month check-in, they are always available to support these critical milestones.
“Many of the team members are still training, and there will be further development within RAQAC which is to be expected within an evolving medical device company, but we have detailed development plans for each team member to help them understand their key objectives and career growth pathway.
“The team’s duties will range from technical compilations for regulatory approval submissions outside of the US, quality management system creation, implementation and certification, quality training, post market surveillance, supplier management, professional services, human factors, clinical investigation, publications, validation and many other activities.”
Rebecca brings over 20 years’ experience working in the medical device industry to her new role at B-Secur, having started her career as an intern with a small medical device company in 2001 as an RAQA assistant.
She said: “The company, known then as HeartSine designed and manufactured defibrillators, and still do today. I spent 18 months in this role then returned to university to finish my degree while continuing to work with the company one day per week.
“After graduating with BSc (Hons) in biomedical engineering, I enrolled in a full-time engineering PhD programme. In 2006, whilst completing my thesis, I accepted a position as clinical research engineer in HeartSine. In 2008 I completed my PhD and in 2010, after building a clinical team, moved into the role of Clinical Manager.
“I spent a lot of time in this role supporting clinical, pre-clinical research and regulatory affairs. In 2017, shortly after HeartSine was acquired, I transitioned to Snr Manager RAQA and led the team through Quality System and RA integration.
“In December 2020, I accepted the position of Global Regulatory and Clinical Affairs Director for Stryker Emergency Care before moving to B-Secur. My whole career has been dedicated to the medical device industry and helping to save lives.”
Rebecca has enjoyed a whirlwind introduction to her new position but is determined to help B-Secur realise our growth ambitions.
She added: “It’s very clear that the executive team live and breathe B-Secur. The last time I had the opportunity to work with a company founder, the late Professor John Anderson, it was an invigorating and inspiring experience.”
“The B-Secur founders are no less passionate. I see endless opportunities and pathways for exponential growth of this business and I’m laser focused in ensuring I support that growth.
“I also believe that our business is very focused on the team and ensuring excellent and regular communication, team building, development and cross functional relationships.”
“In continuing this focus we ensure talent retention and growth internally. We wouldn’t be where we are today without the amazing talent that have come before us who also lead and support with passion, integrity, and determination.”