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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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After this program, participants will:
Carlos Galamba, Vice President of IVD Intelligence & Innovation, RQM+
Carlos Galamba is Vice President of IVD Intelligence & Innovation at RQM+. Carlos joined RQM+ in September 2021 after 7 years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs.
At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA and was a senior biomedical scientist in the UK National Health System, working for some of the largest IVD testing laboratories including Imperial College and University College of London Hospitals. Carlos has a background in haematology, clinical chemistry and haemostasis and specialises in high risk class D IVDs including those used in the fields of transfusion and transplantation.
Kristen Meany, Principal Advisor, RQM+
Kristen Meany is a Principal Advisor at RQM+ with nearly 20 years of experience in regulated industry leading global regulatory teams. She is a strategic and tactical regulatory leader with experience developing regulatory strategies and authoring regulatory submissions for new product development and post-launch changes including Pre-Submissions (Q-Subs), 510(k)s, PMAs, Technical Files and Design Dossiers (EU MDD), and Technical Documentation (EU MDR, EU IVDR) for medical devices and IVDs. Kristen has diverse product knowledge coupled with regulatory affairs expertise in medical devices, IVDs, human tissues, pharmaceuticals, and combination products in the fields of orthopedics, neurological and physical medicine, general and plastic/reconstructive surgery, cardiovascular, dental, and microbiology. She has successfully negotiated with regulatory agencies during the development and review of submissions inclusive of leading meetings with US FDA, EU Notified Bodies, EMA, TGA, and Health Canada. Kristen has also facilitated internal and external audits of regulatory documentation, clinical trials, and quality management systems to ensure continued regulatory compliance.
Kristen holds a Master’s Degree in Bioscience Regulatory Affairs from the Johns Hopkins University, completed Executive Development programs at Harvard and Northwestern Universities, obtained the RAC certification in US and EU regulatory affairs, and is a Certified Quality Auditor.
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