Regulatory affairs

• Biological Safety and toxicological assessment of medical devices.
• Preparation of Biological Evaluation Plan (BEP) Reports (BER) for medical devices in compliance with ISO 10993 standards,
• Review Toxicological Risk Assessment (TRA) reports following ISO 10993-17.
• Development of assessment strategies, creation of templates, and drafting of procedures in collaboration with toxicological and biological evaluations.
• Compilation of comprehensive toxicological profiles for chemicals.
• Performing and summarizing literature searches.
• Evaluation of raw materials for conformity with EU Regulation 2017/745.
• Examination and evaluation of manufacturing processes and agents.
• Investigation of non-conformities and preparation of responses for regulatory authorities.
• Assessment of biocompatibility implications during change control processes.
• Coordination of biocompatibility testing and chemical characterization with certified laboratories.
• Preparation of equivalence demonstration rationales (physical, chemical, material, contact, and biological) in accordance with ISO 10993-18.
• Conducting gap analyses to assess compliance with current standards.
• Justification of "worst-case" device selection for biocompatibility testing.
• Review of Complaints Search Records of Post-Market Surveillance (PMS) data.
• Consult/Support clients to ensure biocompatibility studies are in compliance with most recent regulatory requirements.

Research & Developement

• R &D in medicinal chemistry and preclinical pharmacology and lecturer at leading institutions.
• Performing applied research and supervising Master theses and PhD dissertations.
• Achieving high levels of collaborative behavior.
• Writing of Peer Review Scientific Publications.
• Leading high-impact research projects at the interface of chemistry and biology, early drug discovery and preclinical studies.
• Strong capabilities in project management, defining deliverables, project scheduling and controlling resources, time cost and risks.
• Ability to assess project proposals regarding scientific plausibility and technical feasibility and to work in transverse and multidisciplinary teams.
• Dedicated lecturer with extensive experience in teaching and committed to supporting academic growth, critical thinking, and student success.