Aleix López Fernández
Quality Assurance & Regulatory Affairs Manager and PRRC at DyCare- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
English Professional working proficiency
-
Castellano Native or bilingual proficiency
-
Català Native or bilingual proficiency
Topline Score
Bio
Credentials
-
Cambridge English: Advanced
British CouncilDec, 2014- Sep, 2024
Experience
-
DyCare
-
Spain
-
Wellness and Fitness Services
-
1 - 100 Employee
-
Quality Assurance & Regulatory Affairs Manager and PRRC
-
Oct 2021 - Present
Management of Quality Assurance & Regulatory Affairs Area, from a medical device company of software systems for functional rehabilitation. Among relevant tasks: ▪ Acting as the role PRRC (EU MDR) by ensuring the conformity of the devices before its release, elaborating and updating the product Technical Documentation and DoC, and ensuring the applicable Post-Market and Vigilance activities (incident notifications, SCA…) are conducted when appropriate. ▪ Monitoring processes, managing changes, maintaining and implementing any new required process to the organization QMS (EN ISO 13485 certified), to ensure the compliance with all their requirements (regulatory and customer), and its effectiveness. ▪ Supervision and assurance that both the product development and manufacturing activities and their outputs meet the applicable standards (EN 62304, EN 82304…) required for achieving the product conformity. ▪ Ensure that the applicable GSPRs from EU MDR are being met, and that the product involved has been properly evaluated. It involves, among other, elaborating reports of bench testing, CEP and CER, PMCF, risk management file and PSUR. ▪ Ensure that the local regulatory requirements are being meet (e.g., the maintenance and updating the company’s AEMPS PS license), and generation and maintenance of product market registration/licenses to other countries competent authorities: UK (MHRA). Show less
-
-
-
INNOVAMED Spain
-
Spain
-
Plastics Manufacturing
-
1 - 100 Employee
-
Quality Assurance & Quality Control Manager
-
Jun 2019 - Oct 2021
Management of the QA/QC department of an ISO 13485 certified contract manufacturer performing manufacturing activities of non-sterile plastic injection components and assembly and sterile barrier packaging of medical devices, by establishing, implementing, monitoring and controlling its processes. Among the significant tasks: ▪ Monitoring the QMS processes as management representative for identifying strengths and areas to improve. Management of QMS processes risks and its mitigation actions ▪ Management of the changes and CAPA affecting the QMS, to be in compliance with the internal, the client and the regulatory applicable requirements ▪ Collaboration with technical/production and marketing areas together with the client, in projects for industrialize new products. ▪ Development and management of VMP for equipment qualification and process validation of plastic injection molding, sealing (and its test-method validation) and welding processes as well as cleanrooms performance and cleaning and disinfection of surfaces processes. ▪ In-process controls, quality product and process controls, and cleanroom performance monitoring sample plan definition and standardization according to customer requirements. Release of batches. Show less
-
-
-
Johnson & Johnson
-
Law Practice
-
1 - 100 Employee
-
Regulatory Affairs Specialist
-
Mar 2017 - May 2019
▪ Organization and implementation of the local regulatory actions required by a company’s global MD RA project portfolio, involving the coordination of actions with the stakeholders (marketing, tenders, supply chain,...). ▪ Impact assessment at RA level of the projects, providing support to the global project manager with scheduling estimation of the local actions, monitoring of both status and costs of the projects, obtaining KPIs, following-up of project progress with EMEA and the other involved countries. ▪ Management of the EMEAC region KPIs regarding regulatory activities. ▪ Management of change control of product discontinuation. ▪ Continuous improvement projects; development/improvement of a RA project tracking system, and taking part in an international team to discuss how to implement a new RA information management system in the RA processes of a project involving the EMEAC region. ▪ Interaction intermediary between the HA-Company regarding FSCA management (FSN, FSCA report and traceability) as a back-up. ▪ Conducting trainings to the other countries about both EU Regulatory MDD/MDR framework and Spanish local MD regulations. Also included in “mentorship” program, providing guidance to 2 members about projects/company’s work tasks. Show less
-
-
-
Phibo
-
Belgium
-
Business Consulting and Services
-
Regulatory & QA Analyst
-
Jun 2016 - Mar 2017
▪ Obtaining and maintenance of medical devices CE marking. Elaboration of Declaration of Conformity documents. Obtaining of free sales certificates. ▪ Submission of product health registrations to European health authorities according to local requirements (Spain, Portugal, France). Dossier elaboration for GCC countries. Collaboration in LATAM submission dossiers.▪ Control, tracking and updating of applicable regulation of medical devices ▪ Elaboration of quality system documentation regarding the Regulatory Affairs procedures. ▪ Updating and maintenance of quality system documentation (procedures, work instructions…). ▪ NC monitoring and implantation of immediate actions and CAPA, in the Quality System. ▪ Raw material inspection, qualification of suppliers and batch release of finished product. ▪ Monitoring the Microbiology Control Plan (i.e. bioburden, sterility, endotoxin tests, FUST, packaging…). ▪ OQ/PQ validation stages of ISO 7 & 8 clean rooms requalification and in OQ/PQ of the machining process (Capability Six-pack study of critical dimensions and the preparation of documentation). Show less
-
-
QA & Vigilance Analyst
-
May 2015 - May 2016
▪ Opening, tracking and closure of analysis of quality cases from customers of product and accidents in patients. It includes interaction with customers, using CRM software. ▪ Statistical trend monitoring of quality cases reported by clients. ▪ Improvement of the vigilance and PMS system by implementing some statistical criteria to open or not CAPA. ▪ Management of non-conformities and corrective/preventive actions. ▪ Creation and modification of quality system documentation: procedures, templates and work instructions. ▪ Knowledge of ISO 9001, ISO 13485 and 93/42/EEC directive, having been actively involved in an Audit for ISO 13485. ▪ Key performance indicators of complaints and incidents management. Show less
-
-
-
Combino Pharm, S.L.
-
Malta
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Trainee R&D Project Manager
-
Apr 2014 - Jul 2014
▪ Responsible of the implementation and the training of employees of the Smartsheet software to the management of projects in areas such as R&D, Business Development and variations. ▪ Monitoring of the projects tracking and making its cost analysis ▪ To attend to the project tracking records to verify/noting what actions have been completed and what new actions have to be taken. ▪ Preparation of Project Entry documents (summary of scope, goals, time and cost) ▪ Responsible of the implementation and the training of employees of the Smartsheet software to the management of projects in areas such as R&D, Business Development and variations. ▪ Monitoring of the projects tracking and making its cost analysis ▪ To attend to the project tracking records to verify/noting what actions have been completed and what new actions have to be taken. ▪ Preparation of Project Entry documents (summary of scope, goals, time and cost)
-
-
-
Orangina Schweppes
-
Netherlands
-
Financial Services
-
Trainee Microbiologist technician
-
Jul 2012 - Sep 2012
▪ Microbiological analysis of raw materials, water samples and non-alcoholic beverages. ▪ Monitoring the biological quality of the air as well as the surfaces into the production areas. ▪ Microbiologic control of first productions and pilot plant samples ▪ Diverse microchallange (beverage robustness) ▪ Microbiological analysis of raw materials, water samples and non-alcoholic beverages. ▪ Monitoring the biological quality of the air as well as the surfaces into the production areas. ▪ Microbiologic control of first productions and pilot plant samples ▪ Diverse microchallange (beverage robustness)
-
-
Education
-
2009 - 2013
Universitat Autònoma de Barcelona
Bachelor's Degree, Biotechnology -
2013 - 2014
La Salle BCN
Master's Degree, Project Management -
2021 - 2022
Universitat de Barcelona
Postgraduate Degree, Medical Devices Expert -
2015 - 2015
Escuela de Empresa (On-line)
Upper Course Gestión de Calidad (UNE-EN ISO 9001:2008)
Community
