Senior Regulatory Affairs Specialist
I am currently working with a leading medical device company located in Offaly who have an immediate opening for a Senior regulatory Affairs specialist.If you are looking to join a great company who's main values are their Employees, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.
What will I be doing as a Senior regulatory affairs specialist ?
- 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
- Key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements.
- Integral part of the Risk Management team, supports maintenance of Risk Management Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device and process changes.
- Supports communication between the engineering department and third party electrical safety certifiers
- 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 PMAP 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.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Support assessment and closure of 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.
- Support development of regulatory strategy for and execution of transition from the Medical Device Directive to the Medical Device Regulation.
What I need to be a Senior Regulatory affairs specialist ?
- Third level qualification in an engineering or science discipline
- At least 3+ years' experience in a RA role, or equivalent medical device industry role (i.e. quality, engineering, etc.) within a CE marking, FDA and ISO 13485 regulated medical device environment.
- Demonstrable knowledge of EU Medical Device Directive, 21CFR820, 803 and 807, and ISO 13485 requirements.
If you'd like to discuss the chance of becoming a Senior Regulatory Affairs Specialist, please send across your current CV and we can have a confidential conversation about this opportunity
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales