- Reference: AJ41632
- Job Type: Permanent
- Location: Leinster, Offaly, Other
- Category: Medical Devices
Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will be a key member of the Regulatory Affairs group and is required to demonstrate flexibility as priorities change.
Key role of this position is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devices.
RA Specialist will report to the RA Manager
RA Specialist responsibilities:
- Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body.
- Support reviews of Change Request Notes for change impact on regulatory filings.
- Key member of the New Product Introduction, design control teams and site engineering projects.
- Maintains, updates and submits change data to UL and CSA for device file updates.
- Assists in preparation of regulatory submissions to FDA and other International Regulatory agencies.
- Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CoFS updates, and vigilance and compliance issues.
- Performs regulatory review of product labelling, provides P-MAP review of device promotional literature.
- Perform vigilance reporting and other Agency complaint trending.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Support audit findings or other actions related to regulatory / QMS audits as needed.
- Assist QA in CAPA investigation and root cause analysis, and performance of effectiveness activities.
- Performs other duties as required.
RA Specialist will have:
- Third level qualification in an engineering or science discipline.
- At least 5 years’ experience in an RA role within an FDA and / or ISO 13485 regulated Medical Device environment.
- Experience in internal auditing for compliance to Medical Device QSRs an advantage.
- Project Management experience.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email 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
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!