This global medical device organisation are one of the world's leading manufacturers and suppliers of eyecare and eye health products. The organisation generated over €1 billion in revenue last year and are at the forefront of ophthalmic technology. They currently employ over 1500 individuals, and they are continuing to invest into the development of their site. As such they require a Senior Regulatory Affairs Specialist to join their team. The role can be based either in Dublin or Waterford.
Reporting into the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist will lead activities within the EU Authorised Representative function in Ireland.
In addition, you will be responsible for:
- Acting as deputy to the Regulatory Affairs Manager for all regulatory body communications
- Providing EU Regulatory subject matter support for key projects and activities
- Responsible for regulatory compliance for the EU Authorised Representative
- Developing and maintaining a good knowledge of the product portfolio
- Maintaining the Authorised Representative registration with the HPRA
- Submitting Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN)
- Managing the process for provision of certificates of free sale
- Other duties as assigned by Regulatory Affairs Manager
- Providing advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745
- Supporting key EU MDR work streams
You will have 3-5 years' experience in a similar role in a manufacturing environment. A third level qualification, ideally in engineering or science is required.
This role offers an excellent remuneration package along with superb working conditions.
To discover more about this opportunity, apply now or contact Paul Wheatley at HRM on +353 21 4511190 for a confidential discussion.