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.
SKILLS MUST
* 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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