Job Description
Our client, a healthcare manufacturing company, now seeks a Senior Reg Affairs Specialist to prepare and support vigilance on regulatory data related to the company?s range of medical devices.
The successful candidate will lead the development of design dossiers for submission to Notified Body, while maintaining CE Technical Files aligned with these EU Class III devices and process changes.
Responsibilities of Senior Reg Affairs Specialist:
Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD and other International Regulations.
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
Regulatory representative for NPI design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements.
Lead Risk Management team, maintains files 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) 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.
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.
Requirements for Senior Reg Affairs Specialist:
Bachelor?s Degree in Science, Engineering or similar technical discipline.
5+ years? 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
Must have the ability to communicate effectively with management and fellow peers.
Experience with Risk Management Files (MDHA, D-FMEA, P-FMEA etc.) is desirable.
For further information on this Senior Regulatory Affairs Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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