- Reference: 45438
- Job Type: Permanent
- Location: Leinster, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
Job Title: Regulatory Affairs Specialist
- Review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements.
- Supports the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories.
- Responsible for the development and maintenance of EU product files including Class III design dossiers and Class IIb, IIa and Is technical files which facilitates timely regulatory approvals.
- Responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations.
- Perform analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completes MDV documentation for on-time filing.
Prioritize regulatory workload based on compliance and business objectives, while working with management to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.
- Bachelor’s degree (or equivalent international degree) with 3 years of experience or equivalent combination of education and experience in supporting manufacturing of medical devices.
- Proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications. Must also possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD).
- Experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies.
- Strong writing, data analysis, and communication skills and the ability to handle multiple demanding projects.
For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie