Careers · Regulatory affairs

Senior Regulatory Affairs & Quality Expert — MDR/IVDR (m/f/x)

Healthcare innovation should reach patients, not stop at the regulation.

Ardeevo · Fully remote (Italy) · Full-time or part-time

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English translation. The original job description, in Italian, is on the Italian page.

Ardeevo supports manufacturers of medical devices and in vitro diagnostic medical devices on their path to compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), with Regulatory Affairs and Quality Assurance services.

We do it with an AI-native service model: our AI agents gather the information and structure the regulatory documentation; experts like you review it, validate it and answer for it before it reaches the client. No output leaves Ardeevo without the judgement of an expert.

We are building the core of our regulatory team and are looking for professionals who want to put their experience at the centre of a new way of doing Regulatory Affairs.

01

Why Ardeevo

Your judgement at the centre

AI prepares the documentary groundwork; you bring the value that counts: assessing, correcting, deciding.

Build the method

You join the founding team and work with the product team: your experience helps define our services and our agents.

Technical variety

MD and IVD, different risk classes, software and devices that integrate artificial intelligence.

A stake in the project

Talent joining the first core of the team is offered an employee share ownership plan (ESOP), presented in detail during the selection process.

02

What you will do

  • Review and validate the regulatory outputs produced with our platform: qualification and classification of the device, conformity assessment route, technical documentation, quality management system, post-market surveillance activities.
  • Give reasoned verdicts anchored in the regulation, identifying errors and pointing out where the process needs to improve.
  • Translate the client’s regulatory path into a clear and sustainable strategy.
  • Support clients in their relationship with the Notified Body: preparing the application, handling nonconformities and requests for additional information.
  • Offer direct expert support to clients.
  • Work with the product team on the development of new solutions and on R&D activities.

Ardeevo is not a Notified Body and does not issue certificates: our work is to bring the manufacturer before the Notified Body with a solid dossier.

03

What we are looking for

Requirements

  • A degree in a technical or scientific field (biomedical, electronic or management engineering, physics, chemistry, biology, pharmacy, medicine or related).
  • At least 5 years of experience in Regulatory Affairs and/or Quality Assurance on medical devices and/or IVDs, gained at a Notified Body, a manufacturer, a regulatory consultancy or a medical device testing laboratory (including substance-based devices and biological evaluation).
  • Command of the MDR/IVDR cycle: qualification, classification, conformity assessment route, technical documentation, clinical or performance evaluation, EU declaration of conformity and CE marking, post-market surveillance and vigilance.
  • At least one device or device family taken to CE marking, which you can describe to us in anonymised form (class, conformity assessment route, duration of the project).
  • Direct experience of working with a Notified Body, and up to date on the transitional provisions of the regulations and on the targeted revision of MDR and IVDR under discussion at European level.
  • Working knowledge of ISO 13485 and ISO 14971.
  • Audit experience in at least one of these forms: qualified auditor under a recognised scheme (e.g. ISO 13485 Lead Auditor certified by CQI/IRCA or Exemplar Global); audits conducted for a Notified Body, internal or second-party audits; audits prepared and hosted on the manufacturer’s side.
  • Excellent command of Italian and professional, technical English.

Nice to have

  • Experience as a technical documentation reviewer at a Notified Body, combined with experience building dossiers.
  • Medical device software (IEC 62304, IEC 62366) and devices that incorporate AI, including the requirements of the AI Act (Regulation (EU) 2024/1689).
  • ISO/IEC 27001, ISO/IEC 42001.
  • A master’s degree or specialist training in medical device regulatory disciplines.

How you work

Critical rigour, enjoyment of teamwork, the ability to build relationships with clients and the wish to build new solutions together with the product team.

04

What we offer

Pay (gross annual salary, full-time), based on experience

5–8 years

€40,000–55,000

More than 8 years

€60,000–85,000

Horizontal part-time

Proportional amount

  • Contract: permanent or fixed-term (minimum 6 months).
  • ESOP for the talent of the first core of the team.
  • Company welfare.
  • Access to a national coworking network.
  • Training and exclusive access to events and initiatives of the European startup ecosystem.
  • Fully remote, with travel in Italy and abroad (around 1–2 trips a month). Living in Rome, where our HQ is, or in Naples, where our Tech/IT team works, is a preferential requirement.
  • For profiles with more than 10 years of experience we also consider fractional management arrangements.
05

How to apply

Fill in the form and attach your CV, with a few lines in the message about a certification project you are proud of.

Apply

The selection process

  1. 01

    CV assessment

  2. 02

    Interview with the hiring manager

  3. 03

    Assessment of technical and soft skills

  4. 04

    Final interview with the founding team

We will not ask about your current or past pay.

This job description is open to people of every gender. We process your data according to the notice in the Privacy section of ardeevo.eu.

If you have trouble uploading your files, send your CV to job@ardeevo.eu.

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