This organisation is one of the largest medical technology companies with over 65,000 employees across various sites around the world. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.
They have a strong presence in Ireland, with x5 sites across the country, there is currently a requirement for a new Senior Regulatory Affairs Specialist to join one of their sites in Leinster.
Reporting into the Senior Regulatory Affairs Manager, the Senior Specialist will:
- Maintain mandates under Medical Device Regulation with each of the manufacturers.
- Ensure technical documentation are correct, up to date and available for EU Authorised Representative.
- Assist and ensure devices are registered in EU databases as appropriate.
- Obtain free sale certificates.
- Create, submit and maintain UK product registrations.
- Review and approve advertising / promotional materials to ensure compliance with local and corporate requirements.
- Review and approve product labelling for the region and for specific orders.
- Provide support to marketing / tenders in responding to technical questions from customers and business units.
- Work with regional marketing and business units, using internal systems as applicable, to obtain strategic alignment for product launches and releases as required and circulate approved strategic alignment to commercial team on receipt.
- Input and maintain data, including licenses and registration records in internal regulatory database(s) as required.
- Complete product releases in internal systems for UK and Ireland and for EMA region (i.e. act as EMA IRR Coordinator).
- BSc in Life Sciences with 5+ years relevant experience within the Medical Devices, Diagnostics, or Pharmaceutical industry sector.
- Knowledge of EU Medical Device regulations preferable.
- Experience with approval and maintenance of UKI product registrations.
- Ability to work as a senior individual contributor within a global team structure.
- Project management experience advantageous.
Contact Helena Boyle on (01) 6321870 for a confidential discussion.