We are looking for a Risk Manager (Medical Devices) to provide services to a multinational pharmaceutical company.
TASKS
Support the Risk and DQA team in their activities
Consulting team doing consulting projects.
Work closely with the software engineering team to create an excellent cross‐functional relationship with the different teams involved.
Cross‐functionally manage the quality assurance of digital projects ensuring that deadlines, project plans and quality objectives are met.
Promote organizational compliance with the quality system, on QMS Software and SDLC framework.
Provide quality oversight during risk, Part 11, Annex 11 and regulatory activities.
SKILLSMUST
Strong experience (5+ years) in Quality, including QMS, Design Control, Risk Management, in the area of development, production, planning / quality assurance for Software / In Vitro Diagnostics or Medical Devices.
Experience in setting up and maintaining Quality Management System (QMS) related to Software products, under ISO 13485 and ISO 14971.
Risk management according to ISO 14971.
Advice, guidance and preparation of regulatory documentation prior to commercialization in EU.
Knowledge of MDR (EU) 2017/745 and/or (EU) IVDR 2017/746 regulations.
Fluent in English. Spanish is highly valued.
PLUS
Design and definition of quality systems according to ISO 13485:2016 and/or 21 CFR 820.
Regulatory knowledge for countries outside the European Union and USA (Canada, Japan, ANVISA, etc.), MDSAP, etc.
Dossiers for application for prior license to operate medical device facilities and USA 510(k).
Preparation of technical dossier for CE marking.
SCHEDULE
08/09h - 17/18h from Monday to Friday (flexible)
100% remote position
Categoría IT Ubicaciones Remoto, Portugal (100% remote) Estado remoto Completamente remoto
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