PRECISION IN
REGULATORY AFFAIRS.

“Rebecca is a really lovely, knowledgeable Medical Devices professional, committed to all QARAC system and product solutions management throughout the product lifecycle and beyond. Has worked with electronic QMS and RA systems too, so is very well armed! Very hands on, open/minded, pragmatic, keeps abreast of the latest standards, guidance docs and regulations that span UK, Ireland, Europe and Globally. Dedicated to QMS and RAC compliance daily. Her work ethic is refreshingly supportive and caring with team members, strategic partners and their vision, plus ensuring a true balance is met with an organised mindset and a real pleasure to work with. Highly recommended indeed!”

“I had the opportunity to work with Rebecca Funston on a RAQAC project within the medical device sector, and it proved to be a genuinely valuable experience. She has a remarkable ability to clarify complex regulatory and quality assurance requirements, making the intricacies of medical device compliance both accessible and insightful. Rebecca fostered a collaborative environment where questions were encouraged, and she guided discussions with patience and precision. The process was smooth, well-structured, and left me with a stronger understanding of RAQAC practices as they apply to medical devices.”

“Over the years I've gotten to know Rebecca as an experienced RAQA professional. She's down to earth, pragmatic and I appreciate her ability to not make things bigger than they need to be. It was a pleasure to see her grow in different roles and I've been inspired by that myself. It has always been a pleasure working with Rebecca and I would welcome the opportunity to do so again!”

“I worked closely with Rebecca during the MDR transition of all product portfolios, where her depth of knowledge in MDR, regulatory compliance and QA/RA requirements was immediately clear. She brought a highly professional, structured and collaborative approach, while also being influential in ensuring the business remained focused on achieving the required compliance outcomes within an aggressive project timeline. Rebecca was always pragmatic, commercially aware and clear in her guidance, which made her a strong partner to work with across cross-functional discussions. I would have no hesitation in recommending her to any organisation requiring experienced QA/RA, MDR or regulatory consultancy support.”

“It has been an excellent experience working with Rebecca over several years! She's been great as both as a regulatory consultant as well as leading the internal RAQAC team helping us through successful FDA interactions at a resubmission and submission stage, as well as guiding our product development through clinical, engineering and process challenges for regulatory compliance in multiple geographies. She was essential in setting up QMS and the quality team, training and made audits a breeze. She even went above and beyond interacting with customers investors and was great to ease the team into a regulatory mindset. I highly recommend working with her and truly appreciate her balance for speed and process for a startup.”

“I've had the pleasure of working with Rebecca on several projects and can confidently say she is an exceptional leader and trusted partner. She has successfully led Regulatory, Quality, and Clinical teams across multiple organizations, consistently delivering strong results. Rebecca stands out for her strategic mindset, clear vision, and ability to align teams around shared goals. She consistently drives excellent outcomes, often achieving minor to zero non-conformities during audits and inspections. She brings extensive expertise in global regulatory affairs, including the US FDA, UK regulations, EU MDR, and other international submission pathways. Her practical, solutions-focused approach makes her a valuable asset to any organization. Rebecca is also approachable, collaborative, and a pleasure to work with. She combines a strong results-driven mindset with the ability to build positive relationships across teams and stakeholders. I highly recommend Rebecca to any organization seeking a strong regulatory and quality leader and look forward to working with her again in the future.”