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Regulatory Affairs Specialist, Barcelona

Tecnoempleo

Empresa contratante: BIOSYSTEMS


Salario: Sin Especificar

Regulatory Affairs Specialist en Barcelona
Regulatory Affairs Specialist (Quality Assurance)

We are looking for a person to be part of the Quality Assurance – Regulatory Affairs Department, within the Quality Area. His/her main activities will be involved with the Innovation Area and R&D, working in the Design control of new instruments (including in vitro diagnostics (IVD)), implementation of Regulatory requirements, software validation and preparation of Registration dossiers (FDA). Another field of work will be matching new ways of working in the Innovation Area with the Quality System requirements and adapting the necessary documents.
We need a person with customer service orientation, analytical skills, proactive, autonomous, decisive, goal-oriented, who likes teamwork, and with a great ability to adapt to change.

Functions:

– Implement Design Control of instruments in an agile working environment and prepare and maintain related procedures.
– Document Design Control of instruments, including plans and reports, IVD requirements, software and cybersecurity validation reports.
– Review design outputs according to IVD requirements.
– Implement harmonized standards for IVD instruments.
– Prepare, submit and follow up 510k dossiers for IVD instruments.
– Cooperate with the Innovation Area in the development of new ways of working and match them with Quality System Requirements, and write or change related procedures.

Requirements:

– High education in mechanical, electronic, industrial engineering or similar.
– Fluent English
– At least 2 years in a Quality Assurance – Regulatory affairs Department
– Knowledge of MD or IVD directives (93/42/CEE or 98/79/CE) and of MD or IVD European regulation (UE 2017/745 or 2017/746)
– Knowledge of ISO9001, ISO13485, UNE EN 61010-2-101, UNE EN 61326-2-6, ISO 14971, FDA GMP 21 CFR part 820 and related

Experience in the following fields will be valuable:
o Documentation of Design control of Medical devices or IVD instruments
o Medical devices Risk management and usability reports
o Documentation of Software validation and Cybersecurity of Medical devices or IVD instruments
o FDA 510k dossier preparation for Medical devices (MD)
o Agile team working
o Standard Operating Procedures definition and writing

We offer:

Full working day in a global company in the Biotechnology sector, whose mission is to contribute to improving the health and wellness by providing analytical solutions designed to offer a good user experience.

– Flexible schedule: 39 hours a week
– Location: Barcelona, Bon Pastor area
– To start ASAP
– Employment contract: 1 year, possible indefinite in the future
– Good working atmosphere

MD Directives, IVD Directives, ISO,


 

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