Job Description
A Senior Regulatory Officer is required by Careerwise recruitment to work with our Co. Limerick based medical device client.
Role of this position
1. Drive quality culture in accordance with our quality policies, guidelines and processes.
2. Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO 13485:2016 and IVDR (In Vitro Diagnostics Regulation).
3. Collaborate with the regulatory manager on all new IVDR regulations.
4. Support implementation of company regulatory strategies and providing guidance and expertise.
5. 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.
6. Review and approve the project documentation (risk management documentation, design reports, labelling, etc.).
7. Ensure that updates to the Technical Files and international registrations are conducted appropriately.
JOB REQUIREMENTS
8. A minimum BSc in molecular biology or related discipline and/or a minimum 5 years' experience in a regulatory role.
9. Min 2 years' experience in a Medical Device or an In Vitro Diagnostic Company.
10. Working knowledge of ISO 13485 and ISO 14971 standards.
11. Excellent communication and interpersonal skills.