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

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

Descripción de la vacante

A multinational pharmaceutical company seeks a Risk Manager (Medical Devices) in Spain to ensure quality assurance and compliance with regulations in a remote part-time role. Candidates should have over 5 years of relevant experience in quality management systems and risk management, primarily for software or medical devices. Strong English skills are essential, and knowledge of Spanish is valued.

Formación

• 5+ years of experience in Quality for medical devices or software products.
• Experience with ISO 13485 and ISO 14971.
• Knowledge of MDR regulations.

Responsabilidades

• Support the Risk and DQA team in their activities.
• Manage quality assurance for digital projects.
• Ensure compliance with quality systems.

Conocimientos

Quality Management Systems (QMS)

Risk Management

Design Control

Regulatory Documentation

Fluent English

Spanish (highly valued)

Descripción del empleo

Risk Manager (Medical Devices)

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

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 134:2016 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

Categoría IT Ubicaciones Remoto, Portugal (100% remote) Estado remoto Completamente remoto