Work with us

Recognized all over the world, Ente Certificazione Macchine is a market leader because we put 100% of passion, commitment and innovation in everything we do. ECM is a company founded on work and skills, which is why our staff represents the driving force behind the company’s success.

The ability to hire and grow talent is a fundamental goal for us.

We encourage new ideas and welcome people who stimulate the way we do. Through our diversified and international business, you can learn about and increase ECM’s know-how, helping to transmit our values ​​and at the same time achieve personal and shared goals.

If you want to get in touch with our reality, apply for one of the Open Positions or send us your Curriculum Vitae.

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Open Positions

Ad title Place of work Job type Type of contract Publication date Job position description Apply
Technical Expert and Lead Auditor– Non-Active Medical Devices (MDR 2017/745 + ISO13485:216) Valsamoggia (BO) Full time To be defined 11/09/2026 Read detail

Technical Expert and Lead Auditor– Non-Active Medical Devices (MDR 2017/745 + ISO13485:216)

Technical Expert and Lead Auditor– Non-Active Medical Devices (MDR 2017/745 + ISO13485:216))

ABOUT US

Ente Certificazione Macchine is a European Notified Body No. 1282 under Regulation (EU) 2017/745 and other European product directives. Our mission is to assess the compliance of medical devices with the requirements of the MDR 2017/745 in order to support their certification and placing on the European market.

For our Medical Devices Division, we are looking for a professional to join our team as a Technical Expert and Lead Auditor for non-active medical devices: MDN1104, MDS1001, MDN1213, MDN1204, MDN1206, MDN1102, MDT2009

RESPONSIBILITIES

  • Review the technical documentation of assigned medical devices, assessing compliance with Regulation (EU) 2017/745.
  • Manage certification activities for an international portfolio of medical device manufacturers.
  • Planning and conducting audits at client companies manufacturing medical devices to assess compliance with applicable regulatory requirements, with particular focus on ISO 13485:2016 and Regulation (EU) 2017/745 (MDR).
  • Preparing comprehensive audit reports, documenting non-conformities and supporting evidence, and managing follow-up activities through verification and closure of corrective actions.

REQUIREMENTS

  • University degree or postgraduate qualification in a scientific discipline (Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent).
  • Several years of experience working for Notified Bodies in the assessment of technical files for non-active medical devices.
  • Planning and conducting audits at client companies manufacturing medical devices to assess compliance with applicable regulatory requirements, with particular focus on ISO 13485:2016 and Regulation (EU) 2017/745 (MDR).
  • Preparing comprehensive audit reports, documenting non-conformities and supporting evidence, and managing follow-up activities through verification and closure of corrective actions.
  • Very good knowledge of English (minimum B1 level).
  • Willingness to travel nationally and internationally.
  • Residence in Italy.

WORK LOCATION

The position can be carried out either remotely or from our office in Valsamoggia (Bologna), Italy. Regular presence in the office is required

WHAT WE OFFER

  • Professional growth opportunities in a dynamic and stimulating environment.
  • Possibility of working remotely.
  • The opportunity to join a qualified team committed to product safety and quality.

The position is open to candidates of all genders.
Send CV

Technical Expert and Lead Auditor– Non-Active Medical Devices (MDR 2017/745 + ISO13485:216)
In-house Clinician Valsamoggia (BO) full time To be defined 26/08/2026 Read detail

In-house Clinician

ABOUT US Ente Certificazione Macchine is European Notified Body No. 1282 for Regulation (EU) 2017/745 and other European product directives. Our mission is to verify the compliance of medical devices with the standards required by the MDR 2017/745 regulation for certification purposes prior to placement on the European market.

For our Medical Devices Division, we are looking for an Internal Clinical Evaluator / In-house Clinician.

RESPONSIBILITIES The internal clinical evaluator will be responsible for the critical review of the clinical evaluation of various types of medical devices to verify their compliance with the applicable regulation (EU MDR 2017/745) and satellite regulations/guidelines.

REQUIREMENTS

  • Degree in Medicine and Surgery (MD or equivalent)

  • Two years of clinical research activity with practical experience in conducting or monitoring clinical investigations/trials, or in evaluating clinical data

  • Knowledge of clinical investigation design

  • Solid understanding of the fundamental principles of medical statistics and clinical data evaluation

  • Knowledge of scientific data management (experience with relevant databases such as Embase and Medline)

  • Knowledge of the Medical Device regulatory framework (EU MDR 2017/745, with particular emphasis on Annex XIV and other applicable mandatory documents)

  • Knowledge of risk management applied to Medical Devices

  • Ability to evaluate the appropriateness of PMS/PMCF and PSUR reports produced by manufacturers

LOCATION Work activities can be performed both remotely and at our headquarters in Valsamoggia (BO), Italy. Regular presence in the office is required.

WHAT WE OFFER

  • Professional growth opportunities in a dynamic and stimulating environment

  • Option to work remotely / hybrid remote options

  • Opportunity to be part of a qualified team dedicated to product safety and quality

This job posting is addressed to candidates of all genders.
Send CV

In-house Clinician
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