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EU Medical Devices Operations Manager

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Michelle Kilcar
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EU Medical Devices Operations Manager


Our client is seeking a dynamic individual to lead conformity assessment activities for medical devices and in vitro diagnostics as the EU Medical Devices Operations Manager/Head of Notified Body. Operating under various regulations and directives, including Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, Medical Devices Regulation 2017/745, and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the successful candidate will also oversee a team accredited for management system certification services, such as the Medical Device Single Audit Program (MDSAP) and ISO 13485 Certification Body.

Key Tasks and Responsibilities

  • Lead all conformity assessment activities concerning IVDR devices.
  • Oversee final reviews and decision-making on certification matters.
  • Establish qualification criteria and authorize personnel for conformity assessment activities.
  • Manage resources, including staff, budget, operational plans, and procedures.
  • Chair technical and vigilance review meetings.
  • Manage a team of Quality Management Systems Auditors and Product Reviewers.
  • Conduct verification of personnel performance and oversee initial and ongoing training.
  • Liaise with clients, auditors, and product reviewers on various issues.
  • Contribute to the corrective and preventive action team.
  • Assist in HR recruitment processes for the Medical Devices Division.
  • Contribute to customer relationship management implementation.
  • Collaborate with international partners to expand services.

Qualifications and Experience
  • University degree or equivalent in relevant fields (e.g., medicine, pharmacy, engineering).
  • Experience in conformity assessments on medical devices, especially under IVDR or related laws.
  • Four years of professional experience in healthcare products or related activities, with two years in device design, manufacture, testing, or use.
  • Minimum 2 years' experience in a Notified Body as a site auditor or product reviewer.
  • Knowledge of device legislation and relevant guidance documents.
  • Experience in budgeting, financial management, and forecasting.
  • Proficiency in risk management and device standards.
  • Familiarity with conformity assessment procedures, particularly IVDR.
  • Strong understanding of device technologies and industry practices.
  • Knowledge of quality management systems and related procedures.

  • Extensive knowledge of conformity assessment procedures (e.g., IVDR/IVDD).
  • Qualifications as a lead auditor in ISO 13485, ISO 9001, ISO 17021, MDSAP, IVDD, IVDR.
  • Leadership experience in complex environments.
  • Demonstrated ability to lead and develop high-performing teams.
  • Proficiency in IT systems and file management.
Core Competencies
  • Project management, financial, communication, interpersonal, and teambuilding skills.
  • Exceptional written and presentation abilities.
  • Strong planning, organizational, and administrative skills.

For further information on this role in please contact on Gavin on 087 4108620 or

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

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