Regulatory Affairs Manager
Regulatory Affairs Manager. Company Profile. One of the world’s largest Medical Device companies globally and Ireland’s second biggest employer with a rapidly expanding site based here in Galway, this opportunity will put you at the forefront of improving patient’s quality of life while being involved in new exciting projects. Responsibilities. Oversee domestic and international regulatory activities while taking responsibility for providing leadership for RA across the site, especially in new product manufacturing and market introduction. Manage procedure development and implementation. Review device labelling, product and manufacturing changes with regards to compliance and applicable regulations. Develop and improve regulatory strategy for the site, mainly for NPI projects. Ensure regulatory compliance for products in commercial distribution. Manage relationships with external regulatory bodies in relation to product approvals and post market surveillance. Ensure that the wider working environment supports and follows the Quality Policy and Quality System. Develop commitment for the site to patient safety, product quality and adherence to relevant medical device standards. Assist in QMS and Regulatory audits. Act as RA as SME for quality and compliance improvements. Requirements. Level 8 degree in STEM discipline and 8 years’ experience in a medical device environment with direct regulatory affairs experience. Must have prior people management skills. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: firstname.lastname@example.org. 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.
6 days ago