Regulatory Affairs Engineer - Vitalograph (Ireland) Limited
Vitalograph is one of the world’s leading manufacturers of respiratory diagnostic medical devices, and advanced high-reliability software systems used in clinical drug trials. Our Irish office has been based in Ennis, Co. Clare for over forty years and is responsible for all global manufacturing & R&D. Vitalograph is a family owned company with an innovative 55-year heritage.
Description of Role:
This key hands-on position is to proactively develop processes to assist and drive compliance with global medical device regulations as may apply to the devices under Vitalograph (Ireland) Ltd legal ownership. The primary duties of this role will be to compile new Product Technical Files for each product family, using the Non-IVD Market Authorization Table of Contents structure which becomes effective 2019, using required word searchable pdf copies, structured to ToC format to permit submittal to Notified Bodies and Regulatory Authorities globally. This is essential for the assurance of continuity and accurate assessment of new submittals into key regional markets in a timely manner, in the format to be expected by various jurisdictions, and will provide baseboard for the EU Medical Device Regulations.
Skills & Knowledge Requirements:
This role would suit a graduate degree in Science, Mechanical or Electronic Engineering, or Quality/Regulatory. It requires a high proficiency in the English Language, both oral and written, including the ability to read and conceptualise technical documentation with strong attention to detail.
Expected outcomes or deliverables of the project
- Perform comparative table between existing Technical File structure, STED, ToC and CDST formats, identifying differences in regional expectations
- Develop ToC template using Vitalograph format based upon IMDRF and other guidance final documents, including clarification of layout to cater for requirements of each market jurisdiction. Priority will be for Canada
- Create ToC for each of the Vitalograph product families, including liaison with R&D / SW Teams as needed to create new reports, where there are gaps
- Format each product family ToC into a single, word searchable pdf document using the defined structure, with functional hyperlinks
- Validate the ToC structure, using software tool, as applicable
- Establish each ToC within File Server
- Update Vitalograph SOPs as needed to reflect changes and to formally document the process of ToC creation, validation and maintenance, including method of assurance for timely and coordinated synchronization with the hard copy TF
- Evolve all medical device Technical Files to the new ToC format, ensuring completeness, relevance, currency, and accuracy of content, within the predefined structure of the ToC document, as applies to the relevant jurisdictions
- Perform other duties as may be assigned in support of compliance or QMS activities
- Good scientific and logical attitude, with ability to understand and discuss risk
- Good interpersonal skills with strong written and oral communication skills
- Have the ability to use own initiative
- Strong time management and organisational skills
- Demonstrable high-quality report and documentation presentation skills, with effective clarification notation, noting primary review will be by 3rd party
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