2 x Certification and Inspection Officer – Medical Devices Division - SSO Grade National Standards Authority of IrelandCompany: NSAI
Location: Ballybrit, Galway
Job Overview NSAI is seeking to recruit a certification and inspections officer for medical devices with experience in one or more of the following areas:
Software in medical devicesCardiology devicesRespiratory devicesOphthalmologyDevices incorporating tissue of animal originDrug device combinationsSterilisation and BiocompatibilityThe role will include performing regulatory Quality Management System (QMS) audits under the medical devices regulation, as well as reviewing technical file dossiers submitted by manufacturers for CE mark approval of medical devices. Due to the nature of quality management system audits, this post will require the individual to be off site at least half of the time.
Key Tasks and Responsibilities Conduct registration, surveillance and recertification activities at client facilities to assess their conformity to the related management system standard.Conduct the above audits and prepare the associated pre and post audit documentation in accordance with all NSAI procedures.Perform technical reviews of product Technical documentation to determine compliance with applicable standards and regulations, and to ensure safety and performance.Communicate with assigned clients and NSAI staff to ensure efficient audit planning and timely resolution of questions and non-conformities.Stay abreast of technology and regulatory trends affecting certification.Promote the Certification/Inspection service through the dissemination of information by correspondence, lectures and publications or otherwise as the opportunity arises.Respond to technical enquiries and have responsibility for timely communication and support to clients, administrative staff and Medical Device team members.Maintain strict confidentiality of matters relating to client work at all times.Undertake travel to evaluate applications for certification and registration schemes operated by NSAI.Perform any other duties as may be required by the European Operations Manager.Qualifications and Experience Essential: Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, biotechnology, biomedical science, engineering or other relevant sciences.Four years professional experience in the field of healthcare products or related activities, such as manufacturing, auditing or research of which two years shall be in the design, manufacture, testing or use of the medical device or technology in one or more of the following areas:Software in medical devicesVascularTissue of animal originCardiologyRespiratoryOrthopaedicsOphthalmologyWound careTwo years-experience in the area of quality management.Knowledge of the Medical Device Regulation 2017/745.Knowledge of quality management systems (ISO 13485) and related standards and guidance documents.Knowledge of device legislation, harmonised standards, guidance documents.Knowledge of risk management and related device standards and guidance documents.Experience, training or qualification as QMS (quality management systems) Auditor or QMS Lead Auditor under ISO 13485, with preference given to Notified Body experience.Strong understanding of international regulatory requirements for medical devices, with particular emphasis on European requirements.Understanding and working knowledge of International Standards for medical devices, such as ISO, EN, IEC, ASTM, ANSI and/or AAMI.Ability to analyse data and write clear, concise summary reports.Core Competencies: Good interpersonal skills, with the ability to relate to people at all levels within and outside the NSAI.Ability to work on own initiative and to work as a team member.Strong presentation skills and high level of computer literacy required.Application Requirements: A comprehensive CV detailed as relevant to the position (no longer than 3 pages);A short cover letter/ personal statement (i.e. no more than 2 pages) outlining why you wish to be considered for the post and where you believe your skills and experience meet the requirements for the position.Completed NANDO form.We request that all three documents are submitted in a single word document or PDF where possible. Please note that omission of any or part of the 3 requested documents, as set out above, will render the application incomplete. Incomplete applications will not be considered for the next stage of the selection process.
Closing Date The closing date and time for applications is 16/11/2020. Applications received after the specified deadline will not be accepted. If you do not receive an acknowledgement of receipt of your application within 2 working days of applying, please email ******
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