Collins McNicholas

The purpose of this job function is to coordinate the biomedical activities for new product development.  This will involve the tasks outlined in the Duties and Activities below while playing a supporting role to other team members in the company.  The engineer will work as part of the design team and play an active role in the development of innovative medical devices in accordance with the requirements of International Standards: ISO 13485:2003, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and the Quality Management System.

Main Duties and Responsibilities

– Clinical/Pre-clinical

·         Ensure compliance to the requirements of the EU Directives, Medical Device Regulations and US FDA with respect to pre-clinical and clinical trial activities.

·         Assist in preparation of Design History File documents, summary reports, Technical files/Design Dossier and regulatory submissions to Notified Bodies, FDA and Competent Authorities where necessary

·         Assist in study design and protocol development of pre-clinical biomedical and clinical trials

·         Co-ordinate pre-clinical biomedical research activities

·         Monitor designated Clinical Trial Centres

·         Ensure the integrity of pre-clinical and clinical trial data

·         Control, distribution and management of clinical trial product, where appropriate

·         Assist in pre-clinical biomedical and clinical trial data analysis

·         Management of clinical study centres

·         Assist in the preparation of appropriate pre-clinical and clinical trial interim and final summary reports

·         Assist in regulatory submissions

Pre-clinical biomedical includes: in vitro, in vivo & cadaveric verification & validation studies, and biocompatibility validation.

– Research & Development

·         Participate as an active Design Team Member in research & development processes within current development projects

·         Participate in Design Reviews and Management Reviews, as required

·         Participate as an active member within Project teams to identify the design control and QMS requirements

·         Develop verification and validation protocols as necessary

·         Conduct verification & validation studies as appropriate

·         Conduct in depth research into specific areas of products or development process

Third Level Qualification in Engineering, Biomedical Engineering, Science or related discipline

·         Experience of the medical device industry

·         Quality training through degree or work experience or both

·         Working knowledge of QMS & GLP requirements

·         Knowledge of ISO standards, relevant US CFR’s and EU MDD’s and MDR

·         Knowledge of pre-clinical and clinical product development requirements

·         Knowledge of design- verification and validation of medical devices

·         Knowledge of Clinical Research and associated activities

·         Knowledge of Ethical requirements of Clinical Research

·         Knowledge of Clinical Data Management

·         Knowledge of Regulatory processes and requirements

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