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92,000+ live jobsSenior QARA Engineer
On-site in Barcelona·Full-time·Added 1 month ago (last checked 26 Oct)
Resilience Care
1 open role
Our summary
- Work mode
- On-site, Barcelona
- Contract
- Full-time
- English
- Required
- Experience
- 5+ years
Visa options
The ad doesn’t mention sponsorship
Not a refusal, but not a yes. Worth asking in your first message.
Skills
Nice to have
This job advert was originally written in French.
Requirements
What we're looking for
⚙️ You are the right person if you know how to:
Work on QARA / compliance topics for medical devices (ideally SaMD).
Apply a risk-based approach (e.g., ISO 14971) and translate it into requirements and evidence.
Produce clear, structured, and audit-ready documentation.
Collaborate with Product/Tech teams from the design stage to "build quality into" delivery.
Lead or contribute to PMS, complaints, and CAPA topics.
Work in English, both written and spoken (operational level).
📃 You are the right person if you already have:
5 years of experience in regulatory affairs and/or quality for medical devices (MDR), ideally software/healthcare.
Contributed to the maintenance/improvement of a QMS (ISO 13485).
Worked on technical files / regulatory documentation under MDR.
Participated in post-market surveillance (PMS) activities and/or complaint management.
Nice to have
It is a plus if you:
Have already worked on topics at the interface of quality & information security (e.g., ISO 27001).
Are familiar with international environments (language, requirements, multi-country deployments).
Have already worked on clinical studies.
The role
In a few words: As a Senior QARA Engineer, you ensure the compliance and robustness of our software medical device throughout its entire life cycle, working closely with the product and tech teams.
Your impact: You contribute directly to the continuity of our critical activities (market maintenance, certifications, and clinical research support) by guaranteeing a level of quality and compliance suited to a growing scale-up.
What you'll do
Integrate quality/regulatory requirements from the design phase and throughout the development cycle.
Maintain and improve the quality management system (QMS) and its operational practices.
Produce and maintain up-to-date regulatory documentation (technical files, compliance elements).
Contribute to post-market surveillance (PMS) activities and interfaces related to clinical studies.
Structure complaint monitoring and manage associated CAPAs.
Collaborate with cross-functional teams (product, clinical, security, support) to make pragmatic decisions.
👤 Profile sought
🙂 You are the right person if you have:
Rigor and attention to detail, without losing sight of business impact.
Autonomy and a solution-oriented mindset in a scale-up context.
Ability to challenge with tact and to build consensus without hierarchy.
Sense of priorities, pragmatism, and reliability.
A cross-functional mindset (product, clinical, security, support).
💛 Why join us?
A high-impact health mission, driven by an ambition for personalized medicine.
A product already deployed on a large scale, with concrete quality and compliance challenges.
A scale-up environment: much to build, and real room for maneuver.
Close collaboration with product/tech/clinical teams at the heart of delivery.
Hiring process
Step 1: Exchange with Elena (Talent Acquisition Manager) - 15 min
Step 2: Exchange with Yasmine (Head of Qara) - 45 min
Step 3: Case study with the Qara team - 45 min
Step 4: Team Fit with the Qara team - 30 min
Step 5: Culture fit with Elena - 45 min
Step 6: Strategic vision with Raphaëlle (Chief Operating Officer) - 20 min
GDPR : Your personal data will be processed for the purposes of recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. They will be available only for people involved in the process and erased after 2 years of inactivity.
Under GDPR and as Resilience attach great importance to privacy, please note that you have the right to request access to your personal data, to request that your personal data be rectified or erased. The Data Protection Officer can be contacted at privacy@resilience.care
For more information, please check our privacy policy.
About Resilience Care
In their own words
About the company & team
Resilience Care, a major player in medical remote monitoring and a partner in clinical research, is a French company founded in 2021 with a mission: to provide better care.
Our company offers remote monitoring solutions in oncology, gastroenterology, and psychiatry, based on ePRO collection associated with AI techniques. These rely on a monitoring platform for healthcare professionals, allowing for early detection of side effects for continuous and proactive management, and a mobile application for patients, allowing them to measure and manage their symptoms through tailored resources.
Our solutions enable the optimization of care, enrich the continuous understanding of patients during their care journey, and accelerate clinical research through the collection, structuring, and fine analysis of real-world data. They are currently deployed in routine use for 35,000 patients, in more than 200 healthcare establishments, as well as within the framework of about twenty academic and industrial clinical studies.
We thus put data at the service of care and therapeutic innovation with the ambition of allowing every patient to benefit from personalized medicine.
Here, we do not work in silos. You are joining an agile structure where compliance is a true team sport:
Your Manager: Yasmine, the guardian of the regulatory compliance of our medical devices (MD). She will provide you with her strategic vision of the healthcare sector and will be your support for the most sensitive decisions.
Your core team: A trio of passionate experts. They are your daily contacts for everything related to the QMS, technical files, and audit preparation.
The team's little ➕: A unique context where security, clinical, and regulatory meet to better serve patients, driven by a team that combines rigor and kindness.
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