Regulatory Affairs & MedTech Operations Officer
IDIBELL - AIINANE Project (Hospital-based Medical Software Innovation)
REF. 26-025_SS_AS
About the research group
The aiinane project is a Class IIa Software as a Medical Device (SaMD) developed within the Hospital Universitari de Bellvitge – IDIBELL. The platform supports preoperative risk assessment and clinical decision-making integrated into hospital workflows.
The project is currently being developed as a medical device under MDR and is progressing toward multi-site validation and future CE marking. The initiative combines clinical excellence, regulatory robustness, AI-based decision support, and healthcare operational optimization.
The team includes anesthesiologists, software developers, data scientists, and project leadership, working at the intersection of medicine, regulatory science, and digital health innovation.
The project is under the supervision of the Anesthesia Department of Bellvitge Universitary Hospital and the Perisurgical physiopathology and pain Group from IDIBELL, both leaded by the Anesthesia Head. The Perisurgical physiopathology and pain group carries out research in the areas of traumatology, emergency medicine and emergency medical care.
About the role
We are looking for a highly motivated junior professional to join the AIINANE project, a hospital-based medical software initiative currently progressing through real regulatory, quality and clinical implementation stages within IDIBELL & Hospital environments.
This position offers a rare opportunity to participate directly in the live development of a Software as Medical Device (SaMD), combining regulatory affairs, quality documentation, technical coordination and strategic project execution.
Main responsibilities
- Support maintenance and development of regulatory and quality documentation under MDR / ISO 13485 framework
- Participate in internal QMS documentation and document control
- Assist in technical documentation updates for software medical device evolution
- Contribute to clinical-regulatory documentation preparation
- Support interaction with external regulatory experts and implementation of regulatory roadmap
- Assist in project coordination tasks related to technology transfer and product maturity
- Collaborate with multidisciplinary clinical and technical team
Candidate profile
- Degree in biomedical engineering, pharmacy, life sciences, health technology, regulatory sciences or related fields
- Previous exposure to medical device regulation, MDR, ISO 13485, SaMD or quality systems highly valued
- Strong written English required
- High attention to detail and capacity for structured documentation work
- Ability to work in evolving environments where processes are still being built
- Interest in medical innovation, digital health and hospital-based technology development
Especially valued
- Experience through internships in medical devices or regulated environments
- Familiarity with software medical devices
- Interest in regulatory strategy and product development
- Ability to combine precision with autonomy
What the position offers
- Direct participation in a live Class IIa medical software project
- Exposure to real MDR implementation and quality system development
- Interaction with external regulatory consultancy during roadmap execution
- Multidisciplinary environment combining clinical, technical and innovation domains
- High learning potential in a project with transfer and future scale-up perspective
Conditions
- Estimated start date: May–June 2026
- Contract duration: Permanent by project
- Estimated annual gross salary: 28.500€
- You will be part of a multicultural team. We have a fun loving and friendly international work environment.
- Flexible working schedule - We know you have a life outside of work and we will work with you to make sure it's kept that way.
- Possibility to work some days in remote -Teleworking
- 26 working days of holiday per year
- System of accumulated hours for employees, from 88 to 104 hours depending on the year (11 to 13 working days), to attend to personal matters.
- Benefits of constant training are offered
- We offer and promote diverse and inclusive conditions. Applicants are made free from any discrimination. Specifically IDIBELL works to improve gender equality in all areas with the aim of achieving gender balance, but maintaining the most scrupulous respect to any choice at the level of gender identity. Please express yourself freely, safely and non-binarily, if that's the case.
Deadline: Please submit your application by 20/05/2026
Data protection notice
In compliance with the obligations established in the General Regulation of Data Protection (RGPD), which is the Regulation (EU) 2016/679 of the Parliament and of the Council, of April 27, 2016, and the Organic Law 3/2018, of December 5, Protection of Personal Data and guarantee of digital rights, it is reported that the Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), CIF G58863317, with address Av. Granvia de l'Hospitalet, 199-203, 08908, L'Hospitalet de Llobregat, will process your personal data, as the controller, to apply for the position, maintain communication concerning the status of the candidature, to access the delivered CV; to compare that your data is in accordance with the offers announced by IDIBELL and to verify, where appropriate, that the information provided is accurate. You can find more information in our Privacy Policy at https://idibell.cat/en/privacy-policy-2/, request more information about the data processing carried out and exercise your rights of access, rectification, deletion, opposition, portability, limitation of processing by sending a request at email: dataprotection@idibell.cat. If you consider that you have not obtained satisfaction in exercising your rights, you may submit a claim to Catalan Data Protection Authority.
Our institute
IDIBELL is a research center that integrates the biomedical research of the Bellvitge University Hospital (HUB), the Catalan Institute of Oncology (ICO), and the University of Barcelona in the Bellvitge Campus (UB), and the Viladecans Hospital (HV). The research focuses of IDIBELL are cancer, neuroscience, translational medicine and regenerative medicine. Research, innovation and society are the pivots on which researchers work every day in order to improve the quality of life of citizens.
Observations:
The 'HR Excellence in Research' award represents IDIBELL’s commitment to the implementation of Human Resources policies, which oversee the attracting and development of talent in an open, transparent, and based on personal merit, in alignment with the principles of the European Charter for Researchers and the Code of Conduct for the Recruitment Researchers (Charter and Code).
IDIBELL is committed to the principles of the Code of Conduct for the Recruitment of Researchers of the European Commission and the implementation of open, transparent and merit-based recruitment (OTMR).
The project leading to this labour contract has received funding from ”La Caixa” Foundation under the project code LCF/TR/CI25/56020048.
