As a Regulatory Affairs Specialist, you will be a key member of our 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.
The RA Specialist will report into the RA Manager
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- 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.
- Key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements
- Performs regulatory review of product labelling, provides P-MAP review of device promotional literature.
- Assists in preparation of regulatory submissions to FDA 510(k), EMEA and other International Regulatory agencies.
- 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.
- Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CoFS updates, and vigilance and compliance issues
- Reads related regulatory publications and documents to stay informed about current regulatory actions that may impact owned devices.
- Support audit findings or other actions related to regulatory / QMS audits as needed.
- Performs other duties as required.
- At least 1-3 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
For further information on this Regulatory Affairs Specialist position please contact Gavin Kennedy at The RFT Group at email@example.com / 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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