EU Medical Devices Operations Manager

Overview
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.
  
  

Desirable

• 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.
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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 connect@hero.ie

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