Risk Manager (Medical Devices) | 100% remote (Part-time)

Ambit Iberia; Barcelona; A distancia; EUR 30.000 - 50.000; A tiempo parcial

Descripción de la vacante

A multinational pharmaceutical service provider is seeking a part-time Risk Manager (Medical Devices) to support various quality assurance activities. The ideal candidate should have over 5 years of experience in Quality Management, specifically with QMS and Risk Management, and knowledge of relevant EU regulations. This role allows for 100% remote work and requires fluency in English, with Spanish being highly valued. Candidates will manage the quality aspects of digital projects, ensuring compliance and excellence.

Formación

• 5+ years in Quality Management, Design Control, and Risk Management for software/in vitro diagnostics/medical devices.
• Experience with ISO 13485 and ISO 14971 standards.
• Knowledge of EU regulations: MDR and IVDR.

Responsabilidades

• Support the Risk and DQA team in their activities.
• Ensure quality assurance of digital projects is met.
• Promote compliance with the quality system.

Conocimientos

Quality Management System (QMS)

Risk Management

Regulatory Documentation

English (Fluent)

Spanish (Highly valued)

Descripción del empleo

We are looking for a "Risk Manager (Medical Devices)" to provide services to a multinational pharmaceutical company, working part-time.

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

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 🕘

• Part-time (20h/week - 4h/day)
• 100% remote