Description:
This is a permanent role based at our Client's facility in Ireland.
The successful candidate will have a thorough understanding of both the clinical trial and regulatory requirements required for the Medical Device Industry. Responsibilities of the role will include the following:
• Responsibility for structuring and managing technical files.
• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820
• Responsibility for structuring and managing 510(k), PMA submissions.
• Responsibility for product registration in Europe, USA and other markets as appropriate.
• Responsibility for registration of all Class I devices with the Irish Medicines Board.
• Key member of the new product introduction and design control teams.
• Liaison with the Notified Body and other relevant authorities.
• Responsibility for collections and storage of clinical trials information and ensuring that the regulatory requirements are met.
• Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.
• Responsibility for review and approval of validation and verification documents from a regulatory view point
Applications are invited from candidates with the following background and experience:
• Third level Qualification in Science/Quality, at least 5 years experience in a regulated industry in a similar role.
• Thorough knowledge of the FDA requirements with regard to Clinical Trials and 510K and PMA submissions.
• Thorough knowledge of the EU, MDD requirements.
• Thorough knowledge of the RA requirements in Canada, Australia and Japan.
• Knowledge of medical device quality standards/practises or similar regulated industry
• Good communication and inter-personal skills.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Proven organisational skills.
• High self-motivation.
• Approved External Auditor.
• Willingness to travel on company business
For a full Job Spec and further information on this role please call Deirdre at +353 1 2784671or email your CV in the strictest confidence to dbolger@thornshaw.com