As a RA Specialist, you will support the QA&RA; team in ensuring that our medical devices comply with international regulations.
You will support the preparation and update of technical documentation, the submissions to Notified Bodies and Competent Authorities, and stay ahead of the evolving regulatory landscape in the EU (MDR) and US (FDA).
Key ResponsibilitiesRegulatory Intelligence: Monitor changes in international regulations (e.G. MDR), standards (e.G. ISO, ASTM), and guidance documents (e.G. MDCG, FDA guidances) that impact the company's portfolio.Technical Documentation: Support the creation, update, and maintenance of Technical Files in compliance with EU MDR .
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Labelling & Instructions for Use: Support the review of labels, IFUs (Instructions for Use), and website content to ensure consistency with approved regulatory claims.Regulatory Database Management:
Support the registration of products in EUDAMED and other international databases (e.G., GUDID for UDI).
Post-Market Surveillance (PMS): Collaborate in the drafting of PMS documents (e.G. PMS Plan, PMS Reports, PM Clinical Follow-up and Periodic Safety Update Reports) and assist in gathering PMS data.Certification bodies relationships: Collaborate to the management of the relationship with consultants, Notified Bodies and Competent Authorities regarding submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.Clinical Affairs Interface: Support the Clinical Study Management team in managing adverse event reporting and field safety corrective actions (FSCA) and support the link between clinical evaluation reports (CER) and technical documentation to ensure consistency.Support Quality Management System maintenance: Collaborate to maintain and improve company Qual
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