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A Senior Regulatory Officer is required by Careerwise recruitment to work with our Co. Limerick based medical device client.
Role of this position
* Drive quality culture in accordance with our quality policies, guidelines and processes.
* Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO 13485:2016 and IVDR (In Vitro Diagnostics Regulation).
* Collaborate with the regulatory manager on all new IVDR regulations.
* Support implementation of company regulatory strategies and providing guidance and expertise.
* Compiling and communicating regulatory requirements and gap analysis assessments (e.g. EU IVDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
* Review and approve the project documentation (risk management documentation, design reports, labelling, etc.).
* Ensure that updates to the Technical Files and international registrations are conducted appropriately.
JOB REQUIREMENTS
* A minimum BSc in molecular biology or related discipline and/or a minimum 5 years’ experience in a regulatory role.
* Min 2 years’ experience in a Medical Device or an In Vitro Diagnostic Company.
* Working knowledge of ISO 13485 and ISO 14971 standards.
* Excellent communication and interpersonal skills.
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