Hiring a first QARA profile in a startup
The QARA carries your medical device software's (SaMD) compliance day to day. When to hire your first QARA, why to anticipate, and how to choose the right profile, beyond the CV, for a startup.
Elisa Negra
The QARA carries your medical device software's (SaMD) compliance day to day. When to hire your first QARA, why to anticipate, and how to choose the right profile, beyond the CV, for a startup.
The QARA (Quality Assurance / Regulatory Affairs) is the person who carries compliance day to day. Their recruitment comes up regularly in our conversations with clients. Do you need an in-house skill? At what point? With what competencies and what level of seniority?
This is an operational function. The QARA sets up the Quality Management System (QMS) and keeps it alive, builds the Technical Documentation and documents it as the software's deployed versions evolve, which requires close work with the technical team, then prepares and follows the Notified Body audit.
Several factors weigh on this decision.
The device class. As soon as a Notified Body has to be involved, that is beyond class I, the regulatory workload changes scale and a dedicated skill becomes hard to avoid.
The certification timeline. For a company in initial certification that wants to bring this skill in-house, we recommend hiring ahead of the certification audits. The QARA is then present during the audits, supports the team in the preparation phase, and afterwards maintains the certification over time by keeping the history of exchanges with the Notified Body. Because these profiles are rare, hiring often takes several months and must be anticipated accordingly.
The resources already in place. Sometimes a member of the team wants to specialise and take on this role. We have supported clients in this configuration, gradually training the person in the standards and the expectations of the function. This path takes time, but it builds on knowledge of the product and the company that is already there.
A first QARA ideally combines several qualities.
Understand the company's stakes as a whole, not just compliance for its own sake. The point is all the more sensitive in a digital health startup, where pragmatism matters and where the business model can change quickly.
Be able to challenge the teams without cutting off from them. The role is about improving practices, which requires understanding everyone's work, in particular that of the technical team, and bringing the teams along in regulatory projects. A QARA who operates only through constraint tends to alienate their counterparts, who lose interest in regulatory matters or experience them as friction.
Be able to talk with a Notified Body. Holding a discussion with an auditor calls for a particular posture, which is fairly quickly observable in an interview.
Be rigorous. Rigour applies to documentation, but also to organising regulatory deadlines and audits.
Software knowledge is an asset. QARA who truly master the software world nonetheless remain very rare. So what matters most is the candidate's future progression: their curiosity and appetite for technical subjects, their tech culture, all indicators of their ability to get up to speed with the product quickly. A good profile learns fast when they are genuinely interested.
The regulatory foundation is not caught up as easily. The scarcity of dual-skill profiles sometimes leads to considering a purely technical candidate whose exposure to regulatory work is limited to an occasional contribution, along the lines of 'I have already filled in documentation for a technical file'. The idea sounds appealing, but it inverts the priority. Mastery of the standards, of how they fit together and of regulatory timelines is the foundation of the role: it is acquired slowly, is hard to verify in the field before the audit, and partial knowledge often translates into gaps detected late. Understanding of the technical side, by contrast, settles in faster in a curious person who talks regularly with the product team. The order to favour is therefore someone who masters the standards very well and understands the technical side, rather than the reverse.
A proven setup in a startup combines a junior QARA in-house with an experienced consultant who oversees the work. The junior handles the day-to-day and builds up skills, the consultant brings perspective, secures the structuring choices and reassures the Notified Body.
Another option is to hire, relatively early in the marking project, an autonomous senior profile who has already led a certification. These profiles are rare on the market and expensive: it is better to build a realistic salary range into the financing plan from the outset rather than discovering it at hiring time.
Depending on the actual workload, a full-time hire, a part-time arrangement and external consultant support combine in different ways. What matters is that the person be genuinely available and integrated into the company's processes.
The QARA carries the device's compliance day to day: QMS, technical documentation, classification, audit. Hiring is best started before the emergency, as soon as CE marking beyond class I is on the horizon, so as to follow the setting-up of the foundations. The profile you want understands the company's stakes, can challenge the teams and talk with a Notified Body, and shows genuine tech curiosity. The combination of an in-house junior and an experienced consultant works well, provided the associated budget is anticipated, as these profiles are rare and sought-after.
Sparta Care supports healthcare software and AI system publishers on the quality and regulatory function: defining the right moment and the right profile for a first QARA hire, an experienced consultant to back up a junior QARA and secure the structuring choices, training an employee who wishes to become a QARA, setting up the ISO 13485 QMS and building the technical documentation, regulatory strategy, classification and MDR / AI Act roadmap.
Contact us to shape your quality and regulatory organisation at the right time.
