Experience

MOWOOT

• Spain
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Person responsible for regulatory compliance (PRRC)

  • Apr 2020 - Present

  ensuring that:(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled (incidents, FSCA, trends);(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

• QA/RA & Co-Founder

  • Jun 2014 - Present

  Management of Quality Assurance (QA), Regulatory Affairs (RA) and Risk Management departments.As a Regulatory Affairs Manager: Development of successful regulatory strategies to ensure timely device approvals, in EU and US, and its continuous monitoring (MDD, MDR, FDA), by writing and updating the medical devices technical documentation, being the management representative in the communications with the AEMPS (Spanish MoH) and European Notified Body during 3rd party audits.As a Quality Assurance Manager: Design and implementation, from scratch, of the ISO 13485 Quality Management System (QMS), and monitoring, of all day-to-day activities (Manufacturing, Sales, Distribution, PMS), and also the design, implementation and management of risk management processes.Responsible for identifying, implementing, and monitoring the required actions to ensure compliance with all the applicable Standards and Regulations to MOWOOT II medical device.



Fundació CIM

• Spain
• Industrial Machinery Manufacturing

• Area Rapid Prototyping

  • Feb 2015 - Apr 2015



British Council

• United Kingdom
• Non-profit Organizations
• 700 & Above Employee

• Customer Service Assistant

  • Aug 2014 - Sep 2014



Moebio

• IT Services and IT Consulting

• d•HEALTH Barcelona Fellow

  • Sep 2013 - May 2014

  DHealth Barcelona is the flagship of MOEBIO. A Higher Education Program inspired in the prestigious Stanford University's Biodesign Fellowship. Design Health Barcelona is a pioneering initiative. It is a new educational model of training health transformers.Design Health Barcelona seeks change-makers. It takes the initiative to solve real, global, major challenges in the healthcare and medical technologies industries starting up new, innovative business models, products and services.Design Health Barcelona is a fabric of future leaders. It guides participants beyond their boundaries. It teaches them to think outside the box to identify new opportunities and develop the advancing technologies that will set the future of medical practice and will positively impact people' lives.Design Health Barcelona acts as a catalyst across fields It brings together top students, leading researchers, brilliant entrepreneurs, great investors and innovative organizations and acts as an ignitor fire to make amazing things happen.Design Health Barcelona is disruptive, dynamic, entrepreneurial, social, global, creative, vital, inspiring, enthusiastic, innovative and challenging.Design Health Barcelona is not molecular or genetic research, outdated case studies, a place for lonely individuals. OUR GOALSThe purpose of Design Health Barcelona is to develop an innovative ecosystem to address significant clinical challenges. Our goals are:- Change the face of education, training innovators in the healthcare industry.- Accelerate startups & boost entrepreneurs.- Develop solutions to overcome real, unmet healthcare needs.- Incorporate new products and services into the health systems.