Business Operations Lead- Medical Devices Senior Administrator- Legal Metrology
DublinFull-timePermanent
Business Operations Lead- Medical Devices (56-25)
Job Type
Permanent Full-Time
Remote Work Option
Hybrid
Category
Medical Devices
Location
Dublin 9
Job Grade
PSO
Job Details
JOB DESCRIPTION
Job Title:Business Operations Lead – Medical DevicesDivision:Medical DevicesUpdated:October 2025Reports to:Director of Medical DevicesGrade:Principal Scientific Officer (PSO)No. of direct reports:Team of AssessorsStatus:PermanentLocation:Hybrid working available with occasional attendance in Dublin office required Reference:56-25Job Overview
NSAI is looking to recruit for the position of Business Operations Lead – Medical Devices who will be responsible for managing a team of medical device and/or in vitro diagnostic Assessors (Product Reviewers, Auditors and Lead Auditors) and Internal Clinicians. The People Operations Partner reports into the Business Operations Lead.
NSAI is a Notified Body designated under the following Regulations and Directives:
- Medical Devices Regulation 2017/745,
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
- Medical Device Single Audit Program (MDSAP) auditing organisation
- ISO 13485
- ISO 9001
Key Tasks and Responsibilities
- Identify and attend meetings for sales/marketing purposes, support sales strategy development.
- Oversee resource allocation, utilisation, and availability for certification and quality tasks, supported by the People Operations Partner.
- Manage team development, performance reviews, and objective setting.
- Ensure Assessor billability and achievement of service delivery targets.
- Monitor and report operational KPIs, risks, and target deviations.
- Set operational priorities.
- Support recruitment, on boarding, people development, talent progression, and succession planning.
- Perform 1-2-1 meetings, interim and annual reviews of performance.
- Contribute to the achievement of P/L of the Medical team globally including timely and accurate reporting, achieving the Operational targets the financial year, along with other key performance metrics. This includes all NSAI-MED.
- Responsible for contributing to the forecasting activities and analysis of utilisation for the financial year including roll out of utilisation targets to the NSAI-MED.
- Member of the NBMT, representing the Operations Team.
- Support Technical Planning and Medical Planning Team in identifying visibility of planning Operations personnel, and establishing codes that can be quoted to new clients
- Secure the Operations personnel deliver services as per contractual agreements with clients.
- Member and Chair of the Operations Management Team including timely invites, accurate and timely follow up on actions and minutes.
- Participate and / or support the technical review, vigilance review, significant change committee, Customer relationship management (CRM) implementation and / or other meetings, when required.
- Liaise with external stakeholders including Clients, Competent Authorities and those outside of the Medical Team in the NSAI, in relation to site issues, standards, product, regulatory issues or other areas that require the input of the Operations Officer.
- Support the ongoing monitoring and mentoring of the team in conjunction with the Training and Competency Handler, including ensuring that Operations personnel are calibrated, that relevant training material is developed and annual calibration meetings are performed. Including harmonising Operations personnel personnel within the framework of medical devices.
- Support the inspections by Competent Authority, and for follow-up of findings
- Support processes and procedures to be a fully compliant Notified Body at all times including during audit surveillance activities.
- Secure the Notified Body has relevant Operations personnel on duty at all times excluding Irish bank holidays.
- Other relevant/appropriate duties as requested by the Director of Medical Devices.
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 MDR and/or IVDR or previously applicable law that should have been acquired by working in a Notified Body.
- Adequate experience in compliance assessment, particularly MDSAP and ISO 13485.
- 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. Where the experience is as a site auditor only, demonstratable awareness of Product Review, for example, training is beneficial. Where the experience is as a Product Reviewer only, demonstratable awareness of auditing, for example, training or qualification as internal auditor is beneficial.
- Knowledge of device legislation and relevant guidance documents
- Appropriate knowledge and experience of risk management and related device standards and guidance documents.
- Knowledge of the notified body's quality management system, related procedures and the required qualifications for personnel involved.
- Experience in being audited by national accreditation bodies, MDSAP regulatory authorities and/or competency authorities, and responding to findings.
- The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
- Knowledge of ISO 17021-1.
- Appropriate knowledge and experience of the conformity assessment procedures laid down in the following: MDR/IVDR/MDD/AIMD/IVDD
- Lead Auditor experience in ISO 13485, ISO 9001, MDSAP, MDD, 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.
Full details of the position can be found here : 56-25 - Business Operations Lead- Medical Devices
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