Senior Regulatory Affairs Specialist with 3-5 years of experience working in Regulatory Affairs within the medical devices sector required for permanent role in Co. Offaly.
- Support the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories.
- Reviews and approves all related change orders and performs the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements
- 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
- Represents regulatory affairs on project/product development teams and will be 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
- Assists with international registration requests to support international growth
- Works with their manager to prioritize regulatory workload based on compliance and business objectives
- Bachelor’s Degree in Science / Engineering
- 3-5 years of experience working in Regulatory Affairs within the medical devices sector
- Proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications
- 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
- Ability to handle multiple demanding projects
Please contact Emer Moore to discuss in confidence