Quality Regulatory Specialist & PRRC

• Jul 2022 - Present

Provide regulatory support to all the company departments to ensure the correct application of the latest regulatory framework for medical devices. • Act as the Person Responsible for Regulatory Compliance. • Review and maintain regulatory dossiers and post-market surveillance. • Lead the regulatory framework (CE, FDA, AEMPS), being responsible of submissions to different entities for IVD products. • Liaise with colleagues to organize, track and submit regulatory submissions on a timely basis. Where required provide local QC of submission dossiers prior to dispatch. • Provide input to development teams to assure that regulatory requirements and standards are incorporated. • Preparation and review of SOPs related to IVD product developing, validation, vigilance and risk management. • Collaboration with Marketing team and other departments for development and quality check of Product Information and other materials. • Ensure projects and studies are conducted in accordance with the latest guidelines and legislation. • Provide regulatory input to commercial strategic and operating planning process. Show less

Regulatory Affairs Specialist

• Apr 2021 - Oct 2022

Regulatory support for special projects. Regulatory support for special projects.

Medical Devices and Vigilance Officer

• Jan 2019 - Apr 2021

Provide strategic regulatory guidance and day-to-day support on regulatory, taking into account national and international requirements. Applicate clients’ post-market system and vigilance. - Manage and update registers of medical devices and food supplements. Request national codes. - Review promotional materials and request their authorisation from the Health Authorities. - Draft, review and update Technical Documentation of medical devices and adapt it to the new legislation MDR 2017/745. Ensure the adequacy of the documentation supplied with the products. - Assist clients in the management of their Quality System to comply with ISO 13485 and the MDR. Prepare and review regulatory and quality SOPs. - Prepare and request manufacturing and importing licenses and communication of distribution activities. - Write Clinical Evaluation Reports in different fields such as ophthalmology, dentistry, active devices, dermatology... - Manage incidents with medical devices, undesirable effects of cosmetics and adverse effects of food supplements and their notification to the autorities. - Prepare post-market surveillance and clinical follow-up reports of medical devices. - Data entry and management of adverse events and preparation of pharmacovigilance agreements. - Provide support in the programming, validation and update of the company’s pharmacovigilance database. Show less

Administrative Assistant

• Jun 2018 - Dec 2018

Head of Reservations Management Department & Office Manager

• Jan 2018 - Jun 2018

Monitor the availability of the meeting rooms of all the centres, managing the agenda and keeping track of the reservations. Assist and resolve customer’s requests and incidents, control the facilities and ensure their correct condition and operation. Supervise the work of the reception, IT, maintenance and cleaning staff. Support the back-office team and the Managing Director.

Administrative Assistant

• Nov 2015 - Dec 2017

Regulatory Affairs Assistant

• Jun 2018 - Dec 2018

Assist the Regulatory Affairs Manager in several regulatory tasks: -Realization and updating of dossiers of new products. Review of labels and instructions for use. -Realization of vigilance documentation of medical devices (Post-Market Surveillance reports) and update of Clinical Evaluation Reports. -Realization of SOPs and stability protocols and reports. Assist the Regulatory Affairs Manager in several regulatory tasks: -Realization and updating of dossiers of new products. Review of labels and instructions for use. -Realization of vigilance documentation of medical devices (Post-Market Surveillance reports) and update of Clinical Evaluation Reports. -Realization of SOPs and stability protocols and reports.

Laboratory Analist

• Jul 2014 - Sep 2014

Analysis of the water and food quality, bactericide and fungicide activity assessment. Elaboration of growth medium and sterilization. Analysis of the water and food quality, bactericide and fungicide activity assessment. Elaboration of growth medium and sterilization.