Roderick M.
Scientific Affairs Manager @Haemonetics
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WORK HISTORY
Scientific Affairs Manager @Haemonetics
Scientific Affairs lead for EU MDR‑regulated medical devices, with accountability for clinical evidence strategy, execution, and cross‑functional alignment across the product lifecycle- Own and oversee Clinical Evaluation Reports (CERs) for Class and software‑enabled medical devices in compliance with EU MDR, MDCG guidance, and NB expectations- Lead Post‑Market Clinical Follow‑up (PMCF) strategy and reporting, including survey design, real‑world evidence integration, and clinical benefit–risk justification- Provide scientific governance for clinical evidence planning, acceptance criteria, and state‑of‑the‑art positioning- Act as a key scientific interface with Regulatory, Quality, R&D, Marketing, and external partners- Support inspections, notified body interactions, and audits through robust, audit‑ready documentation
EDUCATION
University of Malta
Bachelor's Degree
University of Malta
Bachelor's Degree, Medical Laboratory Science
SKILLS
ABOUT RODERICK M.
I am a Scientific Affairs Manager with a foundation in medical laboratory science, physiology, and anatomy, and more than 15 years of experience across the pharmaceutical and medical technology sectors. I bring a combination of clinical insight, regulatory expertise, and strategic thinking to the development of Clinical Evaluation Reports (CERs), Post‑Market Surveillance (PMS) and Post‑Market Clinical Follow‑up (PMCF) activities, and the use of real‑world evidence (RWE) to support medical devices.My work focuses on the development and maintenance of CERs under the EU MDR, with particular emphasis on structured literature evaluation, critical appraisal of clinical and post‑market data, and robust benefit–risk assessment. I work closely with cross‑functional global teams to ensure that clinical evidence strategies are scientifically sound, proportionate to device risk, and aligned with MDR Annex XIV and relevant MDCG guidance, including for medical device software and in vitro diagnostic medical devices.I have a strong interest in the practical application of medical statistics and applied biostatistics to clinical evaluation, particularly for the interpretation of observational and real‑world data. I value clear, precise medical writing and evidence‑based decision‑making, and I am motivated by strengthening the role of real‑world evidence in regulatory and post‑market contexts.
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