Lucrezia Favia
Granada
Summary
A career developing position as a Regulatory/Compliance Technician in a successful organization with a performance-oriented environment where progression is directly related to achieved results. Continuous development and learning is a must to make the biggest impact possible. The next step in my career is to transfer my skills into a company delivering human capital and financial management solution services.
Overview
15
15
years of professional experience
Work History
Regulatory Affairs Partner
Roche Pharma
02.2024 - Current
- Supporting the team in ensuring that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature namely physical devices, in vitro diagnostic medical devices and digital devices
- Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
- Coordination of regulatory timelines and deadlines for all assigned projects planned for CT submissions
- Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards
- Using RIM (Regulatory Information Management system) to manage the end-to-end lifecycle of regulatory information and documentation
- Preparing and submitting clinical trials amendments (namely protocols, CMC, LPI, SmPC and brochure amendments) via IRAS and MHRA portal
- Keeping track of changes and/or implementation of regulations relevant to medical devices, such as (but not limited to) Sustainability/Environment, etc
- Advising the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concerns the UK
- Supporting the teams in any interaction with the MHRA that concerns medical devices
- Providing training to people on medical device regulation and all its related aspects
- Providing regulatory expertise on new product development
- Supporting the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information
- Acting as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
Staff Regulatory Affairs Specialist
Becton Dickinson
07.2021 - 02.2024
- Independently managing the worldwide IPD products registrations initiated due to the MDR project. Being the contact person for all inquiries pertaining to these registrations.
- Performing product registration/establishment registration activities on national databases, monitor registration progress and follow up on additional information required from each site, to ensure timeline completion.
- Maintaining and updating the Technical Documentation to ensure timely and accurate records.
- Ensuring timelines and any changed to country regulatory strategies are communicated to the Business RA and MDR team.
- Communicating any approvals or updating registration licenses to the business RA team and the MDR team.
- Managing the MDR file change log with any changes being implemented under the MDD.
- Reviewing notification of changes to determine whether those are substantial changes or not.
- Creating, editing, reviewing, and maintaining regulatory submissions to support country specific marketing approval.
- Reviewing and assembling euMDR technical file's sections.
- Managing Notify Bodies enquiries related to submitted MDR technical files.
- Updating the draft MDR files with any changes made to the device while under notified body review to meet timelines for product release under MDR, in coordination with registration approvals.
- Interfacing with Notify Bodies.
- Reviewing medical device labels to ensure compliance with euMDR regulations and standards.
- Collaborating in the review of clinical evaluation reports.
- Working with Salesforce for the maintenance of regulatory licenses.
Regulatory Affairs Associate
Rayner Intraocular Lenses
03.2020 - 07.2021
- Writing and submitting dossiers for Medical device registration in Europe, Latin America, Russia, Kazakhstan, Uzbekistan, India, Saudi Arabia, United Arab Emirates, Sudan, Turkey, Iraq, Singapore, Indonesia, Qatar, Morocco, Pakistan and South Africa.
- Monitoring registration progress and follow up on additional information required from each site, to ensure timeline completion.
- Developing registration and launch plans in liaison with the regional sales managers to ensure the preparation and submission of registration dossiers, and their remediation.
- Establishing and maintaining regulatory information systems such as technical documentations, quality records, routine reports and regulatory agency communications.
- Interpreting existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
- Ensuring compliance to global regulatory requirements and company policies.
- Reviewing document and product changes for regulatory submission impact.
- Interfacing with regulatory agencies and distributors.
- Supporting equipment, system and process development in-house and with suppliers.
- Participating on product development teams to ensure regulatory requirements are incorporated into the development process.
Quality and Regulatory Affairs Engineer
Deltex Medical Ltd Chichester
02.2019 - 03.2020
- Acquired MDSAP audit certificate;
- Acquired Internal auditer certificate;
- Dealing with customer complaints, CAPAs, Non-conformity;
- Writing annual Post market surveillance reports;
- Writing Regulatory reports for new medical devices projects such as EDM monitors (Cardiology).
- Raising change orders for current procedures in place;
- Conducting internal and supplier audits in compliance with ISO 19011 and ISO 13485;
- Ensuring that the organisation complies with ISO 13485:2016, MDSAP standards and MDD/MDR regulation;
- Hosting 3rd parties’ audits, namely MDSAP, BSI Microbiology audit, Technical files audit and Korean FDA audit to ensure that the organisation complies with Standards ISO 13485:2016;
- Collaborating in maintaining the Company Quality System following ISO standards 13485:2016;
- Improving and implementing new procedures for Quality, Quality Policy, and Quality Manual.
Technical Application Scientist
Illumina Ltd Cambridge
09.2017 - 02.2019
- Professionally troubleshooting client’s technical questions and complains;
- Collaborating with QA in the documentation of complaint cases previous FDA reviews;
- Collaborating with the Regulatory Affairs department;
- Ensuring accurate and timely reports of Serious Adverse Events and their follow up;
- Preparing activities associated with audits and regulatory inspections in liaison with local Study Manager and QA;
- Monitoring monthly quality issue process by escalating systematic or serious quality, CSP or GCP compliance issues to Local Management/Local QA;
- Delivering trainings and presentations to colleagues and new starters.
Cytogeneticist-Genetic Technologist
Leicester Royal Infirmary
05.2015 - 09.2017
- Undertaking technical and scientific duties;
- High-quality and accurate cytogenetic analysis; constitutional chromosome analysis, metaphase/interphase FISH using bright field, phase contrast and fluorescent microscope along with analysis system;
- Participate in internal and external audit;
- Participate in journal clubs as part of my CPD programme delivering monthly presentations;
- Collaborating with R&D by introducing and validating new technical developments; Dealing with nonconformities including root cause analysis, implementing correct and preventive actions.
- Training new starters.
Researcher
Nottingham University, School of Life Sciences
10.2013 - 04.2015
- Research the effects of mutated polarity proteins on cell shape and cell morphology using Drosophila Melanogaster as a scientific model for the study. This involved the use of confocal microscope Leica and Zeiss together with fluorescence techniques and FRET.
- Co-author of the scientific paper titled “A gradient of Rac activity determines protrusion form and position in a 3-dimensional epithelial sheet”; published in Nature Communication in May 2017.
- DNA and RNA extraction, cloning, cell cultures.
- Writing scientific reports, abstracts and critical literature reviews.
Volunteer Trainee Andrologist
Queen Medical Center, Nottingham, United Kingdom
01.2013 - 07.2013
- Spermiogram and Cryoconservation of semen.
- Research project in the effects that particular materials used to treat the semen, generate on the vitality, morphology and motility of the spermatic cell.
Internship as trainee Andrologist
S.I.S.Me.R
03.2011 - 10.2011
- Use of the Polarization inverted microscope” LeicaDMI3000B” and cryostat-fluorescence microscopy.
- Treatment of the sperm cell for ICSI (Intracytoplasmatic Sperm Injection).
Education
Master Degree - Medical Biotechnology and Molecular Biology
University of Biotechnological sciences
Bari, Italy10-2011
Bachelor Degree - Pharmaceutics Biotechnology
University of Biotechnological Sciences
Bari, Italy10-2009
Skills
- ISO 15189
- ISO 13485
- MDSAP standards
- MDD
- MDR
- IVDR
- Class I medical devices
- Class IIa medical devices
- Class IIb medical devices
- Class III medical devices
- FDA 510k
- Product risk classification
- IVDD
- IVDR Classification
- MDD Classification
- MDR Classification
- Analytical skills
- Judgment skills
- Dexterity skills
- Teamwork
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Database management
- Document management
- Self-motivation
- Problem-solving
- Troubleshooting
- Ability to learn new techniques
- Accountability
- Capacity to work under stress
- Ability to meet deadlines
- Meticulousness
- Pragmatism
- Eagerness to learn
- Goal orientation
- Interpersonal skills
- Regulatory compliance
- Clinical trial management
- Technical documentation
- Quality assurance
- Project coordination
- Regulatory submission
- Team leadership
- Data analysis
- Problem solving
- Professionalism
- Oral and written communication
Languages
Spanish
Advanced
C1
Italian
Proficient
C2
English
Proficient
C2
Interests
- Swimming and baking
Timeline
Regulatory Affairs Partner
Roche Pharma
02.2024 - Current
Staff Regulatory Affairs Specialist
Becton Dickinson
07.2021 - 02.2024
Regulatory Affairs Associate
Rayner Intraocular Lenses
03.2020 - 07.2021
Quality and Regulatory Affairs Engineer
Deltex Medical Ltd Chichester
02.2019 - 03.2020
Technical Application Scientist
Illumina Ltd Cambridge
09.2017 - 02.2019
Cytogeneticist-Genetic Technologist
Leicester Royal Infirmary
05.2015 - 09.2017
Researcher
Nottingham University, School of Life Sciences
10.2013 - 04.2015
Volunteer Trainee Andrologist
Queen Medical Center, Nottingham, United Kingdom
01.2013 - 07.2013
Internship as trainee Andrologist
S.I.S.Me.R
03.2011 - 10.2011
Master Degree - Medical Biotechnology and Molecular Biology
University of Biotechnological sciences
Bachelor Degree - Pharmaceutics Biotechnology
University of Biotechnological Sciences