Regulatory Affairs Manager
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.
- 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.
- 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 Recruitment T: +353 91 455305 E: email@example.com
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