Senior RA Specialist - Offaly -60k

Offaly  ‐ Onsite
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Keywords

Description

My Client a critical care medical device company based in Tullamore Co. Offaly is seeking a Senior Regulatory Affairs Specialist.

As a Senior Regulatory Affairs Specialist, you will be a key member of the Regulatory Affairs group and 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. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations.

Duties
*Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintains currency of CE Technical Files aligned with device and process changes.
*Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicable
*Integral part of the Risk Management team, maintains Risk Management Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device and process changes.
*Maintains, updates and submits change data to UL and CSA for device file updates
*Assists in preparation of regulatory submissions to FDA 510(k), LAPAC and other International Regulatory agencies.
*Performs regulatory review of product labelling, provides P-MAP review of device promotional literature.
*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.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
*Third level qualification in an engineering or science discipline. EXPERIENCE REQUIRED
*At least 5-7 year's experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment.
*Demonstrable knowledge of 21CFR820, 803 and 807, and ISO 13485 requirements
*Experience in internal auditing for compliance to Medical Device QSRs an advantage

This is an urgent requirement if you are interested in this great opportunity please contact me as soon as possible Anna Mooney . Or apply below with an up to date CV.

To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
07.09.2013
Project ID:
595435
Contract type
Permanent
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