Job description
Sector: Science & Pharma
Contact Email: christopher.otoole@collinsmcnicholas.ie
Job Ref: 19273
The purpose of this job function is to support the preclinical/clinical activities. This will involve the tasks outlined in the Duties and Activities below. This person will work as part of the product
development team and play an active role in the development of innovative medical devices in accordance with the requirements of International Standards: ISO 13485:2016, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Regulations (EU) 2017/745 and our clients Quality Management System.
Responsibilities
- Assist in preparation of pre-clinical and clinical documentation in compliance with EU MDR and US FDA requirements
- Assist in co-ordinating pre-clinical 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
- Maintain inventory log(s) Control for clinical trial product, where appropriate
- Maintain Commercial data log(s)
- Procure preclinical consumables as required
- Assist in case report form design and EDC development
- Maintain supply of clinical documentation- e.g. clinical study worksheet folders
- Assist in literature, MAUDE & UDAMED database searches
- Assist in verification & validation studies as appropriate
Requirements:
- Experience of the medical device industry
- Working knowledge of QMS, GCP & GLP requirements
- Knowledge of pre-clinical and clinical product development requirements
- Knowledge of design- verification and validation of medical devices
- Must have good communication skills
- Must be able to work well in a team environment
- Must be able to work autonomously and take ownership of activities
- Strong technical Report Writing skills
- Ability to do literature searches and online database searches
- Working knowledge of general office Computer Software and Hardware
- Willing to learn and develop
For more information on this role and a confidential discussion please contact Chris O Toole
christopher.otoole@collinsmcnicholas.ie
091706713
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