EU Medical Devices Operations Manager (EMDOM) (14-24)

Contract - Fixed Term

Hybrid

Medical Devices

Dublin

PSO


Job Details

JOB DESCRIPTION
 
JOB TITLE:EU Medical Devices Operations Manager  
DIVISION:Medical Devices  
UPDATED:April 2024 
REPORTS TO:Director of Medical Devices
GRADE:Principal Scientific Officer (PSO) 
TENURE:5 year Fixed Term Contract
LOCATIONSantry, Dublin 9 or Galway (Hybrid working available) 
REFERENCE14-24 & 15-24

Job Overview
NSAI is looking to recruit for the position of EU Medical Devices Operations Manager/ Head of Notified Body who will be responsible for managing a team of medical device and/or in vitro diagnostic product technical file reviewers and auditors. 
NSAI is a Notified Body designated under the following Regulations and Directives:
  • 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,
  • In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
And is accredited to the following management system certification services:
  • Medical Device Single Audit Program (MDSAP) recognised auditing organisation
  • ISO 13485 Certification Body
  • ISO 9001 Certification Body
Key Tasks and Responsibilities
  • The Head of Notified Body will have overall responsibility for all conformity assessment activities in relation to IVDR devices.
  • This person will be responsible for or final reviews and decision-making on certification.
  • Responsible for making the decisions on issuing, suspending, restricting, re-instating or withdrawing of certificates and for defining the period of certification. This person should base their decision on the final review report and supporting documentation according to Section 4.8 of Annex VII.
  • Establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities.
  • Manage the resources of the European Medical Device division, including responsibility for staff, budget (including financial reports for the CEO and Executive Management Team), operational plans and procedures
  • Chair technical review, vigilance review and significant change committee meetings. 
  • Responsible for ultimate determination of certificates on all Medical Device EU Annex IX, XII Certificates and IVDR Medical Device EU Annex IX Certificates. 
  • Manage a team of Quality Management Systems (QMS) Auditors and Product Reviewers.
  • Selection, verification of competency and authorization of the personnel to carry out conformity assessment activities within the organisation.
  • Conduct the verification of the performance of the personnel and the definition and the verification of their initial and ongoing training.
  • Liaise with Clients, Auditors and Product Reviewers in relation to site issues, standards, product and regulatory issues.
  • Member of the corrective and preventive action (CAPA) team.
  • Assign competency and authorise product reviewers & QMS auditors based on IVDR/IVDD/ ISO 13485. 
  • Ensure ongoing monitoring and mentoring of the team in conjunction with the Training and Education Officer. 
  • Assist HR in the recruitment process for new staff in the Medical Devices Division.
  • Member of the Customer relationship management (CRM) implementation team. 
  • Work in conjunction with the US Medical Devices Operations Manager, Medical Device Single Audit Program (MDSAP) program manager and Chief Clinical Evaluator. 
  • Assist with client quotations, contract reviews and onboarding new clients for conformity assessment activities. 
  • Act as a Competent Authority liaison. 
  • Work closely with the management team to expand NSAI’s services internationally and participate and contribute in the development of supporting business and operational strategies.
  • Participate as a member of the NSAI Leadership Management Team (LMT).
  • Other relevant/appropriate duties as requested by NSAI management.

Qualifications and Experience
Essential
  • Successful completion of a university or a technical college degree or equivalent qualification in relevant studies such as medicine, pharmacy, engineering or other relevant sciences.
  • Adequate experience in conformity assessments on medical devices under the IVDR or previously applicable law that should have been acquired by working in a Notified Body
  • Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
  • Minimum 2 years’ experience working in a Notified Body as a site auditor and/or product reviewer.
  • Knowledge of device legislation and relevant guidance documents
  • Appropriate knowledge and experience of budgeting (to include financial management and forecasting skills to evaluate business performance against budget/revenue)
  • Appropriate knowledge and experience of risk management and related device standards and guidance documents.
  • Appropriate knowledge and experience of the conformity assessment procedures in the areas of IVDR. 
  • A broad base of knowledge of device technologies, including sufficient experience of conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices.
  • Knowledge of the notified body's quality management system, related procedures and the required qualifications for personnel involved.
  • The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
Desirable
  • Appropriate knowledge and experience of the conformity assessment procedures laid down in the following: IVDR/IVDD.
  • A qualified lead auditor with extensive experience in ISO 13485, ISO 9001, ISO 17021, MDSAP, IVDD, IVDR.
  • Professional experience leading and managing teams in a relevant complex and specialised environment. 
  • Demonstrable experience of leading high-performing teams and a proven ability to develop, coach and mentor staff.
  • Experience of a range of IT systems and an excellent working knowledge of file management and quality systems.  

Core Competencies
  • Strong project management, financial, communication, interpersonal and teambuilding skills. 
  • Exceptional written and presentation skills. 
  • Excellent planning, organisational and administrative skills.

This job specification is intended as a guide to the general range of duties for this post. It is intended to be neither definitive nor restrictive and will be subject to periodic review with the post holder.
 
For further details of this post, please see the Candidate Booklet.