Regulatory & Business Operations Officer (Medical Software – SaMD)

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

The Regulatory & Business Operations Officer will support the regulatory consolidation, quality system development, and strategic market preparation of aiinane during its next two-year development phase.

The selected candidate will play a key role in:

• Supporting QMS implementation and maintenance (ISO 13485-aligned environment)
• Contributing to Technical Documentation updates (MDR 2017/745)
• Supporting risk management and change control processes
• Assisting in clinical evaluation documentation and regulatory roadmap preparation
• Coordinating documentation for clinical investigations and regulatory submissions
• Supporting CE marking preparation pathway
• Assisting in health-economic modelling and ROI documentation
• Preparing materials for hospital stakeholders and funding opportunities
• Contributing to market access strategy and structured business planning

This is a strategic execution role with high growth potential in regulatory leadership and digital health innovation.

Job requirements

Professional experience

• 1 to 4 years of experience in medical device regulatory affairs, quality systems, or digital health environments
• Experience working with MDR, ISO 13485, ISO 14971, or IEC 62304 environments is highly desirable

Education and training

•  Bachelors degree in Biomedical Engineering, Life Sciences, Biotechnology, Pharmacy, Health Technology, or related field 

Technical & soft skills

• Strong organizational and documentation skills
• Structured and analytical mindset
• Ability to work autonomously in a multidisciplinary clinicaltechnical environment
• High attention to detail
• Strong written communication skills
• Proactive and solution-oriented attitude

Languages

• Good command of the English language
•  Knowledge of Spanish or Catalan will be considered an asset.

We will value, but not required

• Experience with Software as a Medical Device (SaMD)
• Participation in audits or notified body interactions
• Knowledge of EU AI Act or digital health regulatory landscape
• Experience in grant writing or healthcare innovation projects
• Knowledge of health economics or hospital procurement processes
• Experience in startup or spin-off environments.
• Candidates who are currently pursuing or in the process of completing a PhD or a Masters degree are encouraged to apply.

What do we offer

•  No. of positions: 1

•  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.

•  Paid leave package

•  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  12/04/2026

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.