• Mar 2021 - Present

Organizational development of the company;Management of business functions and processes:• R&D and Regulatory Affairs;• Marketing and sales;• Scientific marketing;• Production and logistics;• Purchase of goods and services;• Collaboration with CFO for administration and finance

• Apr 2015 - Feb 2021

Responsible for developing and maintaining the Company’s Quality Management System (QMS), in accordance with standard ISO 13485 and ISO 9001, as well as overseeing the registration process for both medical devices and biocidal products, handling the interactions with authorities. • Preparing and managing the product Technical Files for Medical Devices IIa and product CE marking, interacting with the notified body.• Managing the registration process of new products, both medical devices and biocides, with the regulatory authorities from various countries around the world (EMEA, Asia Pacific and South America).• Managing the documents of the QMS included the quality agreements with outsourced manufactures and clients.• Conducting batch record review for the product release, coordinating CAPA activities and investigative work in regards to deviations and non-conformances.• Conducting internal and external supplier audits, leading inspections by regulatory authorities and customers. Show less

• Nov 2013 - Feb 2021

• Creating and managing technical documents (MSDS, Labels, IFUs, etc.) for end-users in accordance with current directives and regulations (CLP, REAHC, Directive 93/42/EEC, etc.).• Working collaboratively with R&D, Marketing and Manufacturing in the assessment of functionality and effectiveness of products.• Collaboration with several support centers, including hospitals, doctors and external laboratories to plan new testing and methodologies.• Supporting Sales and Marketing in training the distributors and the end users.• Liaising with scientific advisors, consultants and service providers. Show less

Scientist

• Sep 2011 - Sep 2013

I was involved in the development of innovative technologies that simplify antibody, protein and oligonucleotide labelling for use in R&D applications, drug discovery and the development of diagnostic kits. • Design and development of new conjugation methods as well as new antibody labelling systems, working with fluorophores and enzymes. • Nanoparticle surface modification, enhancing stability and permitting covalent attachment to a variety of molecules. • Performance of immunoassays such as ELISA and lateral flow. • Experience in chemical purification using chromatographic techniques, SDS-PAGE and wet chemistry analysis. • Experience in process and assay method development and validation. • Documenting experimental work, analyzing data and reporting results. • Development and management of the ISO quality system. Show less

Pharmacist

• May 2010 - Mar 2011

• Selling pharmaceutical and parapharmaceutical products. • Dispensing and administration of prescriptions. • Stock management. • Providing pharmaceutical advice to customers. • Selling pharmaceutical and parapharmaceutical products. • Dispensing and administration of prescriptions. • Stock management. • Providing pharmaceutical advice to customers.

Researcher

• Feb 2009 - Mar 2010

Internship during the final year of the Master degree in order to develop an experimental thesis focused on the characterization, separation and study of the interaction between DNA and a new group of anticancer drugs. • Development and validation of a HPLC method for separation and quantification of alkaloid compounds. • Spectroscopy analysis and interpretation: UV and fluorescence spectroscopy. Publications: • V. González-Ruiz, P. Mussardo, E. Corda, S. Girotti, A.I. Olives, M.A. Martín; Liquid chromatographic analysis of the anticancer alkaloid luotonin A and some new derivatives in human serum samples Journal Separation Science 2010, 33, 2086–2093) • P. Mussardo, E. Corda, V. González-Ruiz, J. Rajesh, S. Girotti, M.A. Martín, A.I. Olives; Study of non-covalent interactions of luotonin A derivates and the DNA minor groove as a first step in the study of their analytical potential as DNA probes Analitycal & Bionalitycal Chemistry 2011, 400, 321-7; • P. Mussardo, V. González-Ruiz, J. Rajesh, E. Corda, S. Girotti, A.I. Olives, M.A. Martín; Fluorescence quenching studies of luotonin A and derivatives as a valuable evidence of their interaction with DNA Luminescence 2010; 25, 259) Show less