Senior Regulatory Affairs Specialist

Sigmar Recruitment

Galway

Senior Regulatory Affairs Specialist. Responsibilities. Work with the national and international regulatory affairs teams to provide support in change management for products and also addressing potential issues and questions for regulatory bodies. Prepare regulatory submissions and CE Mark Technical files for NPD and product change projects and activities. Addressing MDR and remediation issues and applying all necessary actions across the business portfolios. Review documentation for products live in the market in relation to any changes and also interacting with the FDA directly and indirectly plus reviewing with management any significant issues. Maintain and update insight database. Ensure focus of business and departments on compliance to global regulations and international standards. Requirements. Level 8 degree with 4 years or more experience in QA and RA within a medical device or similarly regulated environment. Working knowledge of Medical Device QMS under 21 CFR 820, ISO13483/MDD and MDR. Would be beneficial to have ISO, GHTF and ICH standards experience. Preferable to have experience in medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.

1999 days ago