Regulatory Affairs and Quality Manager

Milan, Metropolitan City of Milan, Italy

Description

Empatica

We're an affective computing company focused on human data analytics, with offices in Downtown Boston, MA and Milan, Italy.

Our mission is to provide intelligent technology that is friendly, caring and more human.
We design and develop medical-quality wearable devices aimed to improve people's emotional well-being and save lives. Embrace2, our hero product, is the only wrist-worn seizure monitor cleared by the FDA, designed to help prevent SUDEP (Sudden Unexpected Death in Epilepsy).

We believe in a work environment that fosters autonomy, mastery and purpose. We are a team of passionate people from all over the world bringing high levels of creativity to our everyday work.

Watch the recent TEDx talk delivered by our Co-Founder and Chief Scientist Rosalind Picard to learn more about the history of Empatica and what drives our commitment to great work: https://www.ted.com/talks/rosalind_picard_an_ai_smartwatch_that_detects_seizures_and_saves_lives


The new team player

We are looking for a Manager of Regulatory Affairs and Quality with super organizational skills able to implement regulatory strategies for Empatica products. He/she will help lead regulatory in support of Empatica efforts to obtain approvals to market new medical wearable devices for the US and EU and provide ongoing regulatory support for all marketed medical devices. The Manager of Regulatory Affairs will be a key member of project teams, responsible for the evaluation of product concepts and opportunities from the regulatory perspective.


What you'll do

You will be responsible for handling pre-market submissions to the FDA and managing CE Medical certification interacting with notified bodies in the EU. You will also be responsible for the quality within Empatica defining SOPs related to product design, development, production and support. You will conduct internal audits and training and will supervise external audits from external entities.


You will join an elite team of hard-working and passionate people and will be involved in:


Why work at Empatica

At Empatica you will be able express your potential. We need people that can take decisions and achieve results with total independence. In addition we need creative people that are able to find solutions that could be more efficient in terms of time or resources.

Requirements

As the ideal candidate for this position you:


The ideal candidate for Empatica:


Benefits

We expect a lot from you, but your efforts will be rewarded by great benefits:

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