Description
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.Responsibilities:
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.
Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements
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.
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 for devices, and develop necessary solutions to mitigate against repeats, and improve process.
EXPERIENCE REQUIRED
Third level qualification in an engineering or science discipline.
At least 3 year's experience in an RA role within an FDA regulated medical device environment.