Empatica logo Empatica

Quality & Regulatory Affairs Specialist

Created on 26-02-2020
Location Milan

Description

EmpaticaOur mission is to provide intelligent technology that is friendly, caring and more human.

We build AI systems to understand human behavior through wearable sensors. Our technology empowers thousands of patients, clinicians and researchers with real-time human insight, driven by physiological and behavioural biomarkers.

We design and develop medical-quality wearable devices aimed to save lives and improve people's emotional well-being. Embrace2, our hero product, is the only wrist-worn seizure monitor cleared by the FDA.

We believe in a work environment that fosters autonomy, mastery and purpose. Each employee at Empatica is mentored and supported in their personal and professional development goals. 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 Quality & Regulatory Affairs Specialist with super organizational skills to support the implementation of Empatica QMS and regulatory strategies for Empatica products. As a member of the Quality and Regulatory Affairs department you will help in supporting Empatica’s efforts to obtain approvals to market new medical devices for the US and EU and provide ongoing quality system and regulatory support for all currently marketed medical devices.

By working at Empatica, the Quality & Regulatory Affairs Specialist has a real opportunity to improve lives around the world, as part of a tight-knit team who share knowledge and are eager to keep learning and improving to create top-notch products that have a meaningful impact. You will be accountable for the implementation and maintenance of specific areas of Empatica QMS such as production-related activities, suppliers monitoring and software validation.

Your contribution to the mission

  • Create new Quality Management System documents, and maintain the existing ones updated.
  • Continuously monitor changes in the internal teams' workflow and make sure that they are compliant with regulations.
  • Prepare documentation for audits.
  • Collaborate and network with numerous internal teams including Management, Ops, Business development, Hardware, Data, Software development, and Firmware development.
  • Verify and document that internal workflows and procedures are compliant with ISO/IEC standards.

Requirements

The ideal candidate for this position you

  • Have a genuine interest, passion and motivation for Empatica's mission.
  • Have a strong academic background, BS or MS in scientific disciplines is a plus.
  • Have at least 3 years experience as a Quality Assurance, Document Control Specialist or Technical writer in a company that designs/manufactures medical devices, wearable devices or IoT devices.
  • Have strong knowledge and experience working with ISO standards (13485, 14971, ...).
  • Have direct experience regarding Quality Assurance and Quality Control of medical device manufacturing environment.
  • Have excellent analytical and problem-solving skills.
  • Are an autonomous person, with good organization and management skills.

Additional Non-Mandatory Requirements

  • Have experience in clinical research or have conducted a clinical trial.
  • Knowledge and experience working with IEC standards (60601, 62304, ...).
  • Knowledge and experience working with FDA 510(k) clearance process.
  • Have experience in managing or participating in Quality Audits.
  • Have experience in validation of software used as support of quality system processes.
  • Have past experience with privacy policy; experience with GDPR is a plus.
The ideal candidate for Empatica
  • Is a very quick learner.
  • Is a very quick learner (it’s not a typo).
  • Is fun and easy to work with.
  • Has an excellent execution mindset.
  • Is a hard-worker and collaborative.
  • Has outstanding planning, time management and multitasking skills.
  • Is focused on quality and excellence.
  • Is flexible in terms of working time.
  • Is a problem-solving hustler who can take on any big or small project.
  • Is passionate about our products and our mission.
  • Is proficient in English (mother tongue is highly appreciated).

Benefits

  • Competitive salary
  • We have offices in Milan City Center (where this position is based), Downtown Boston. And every summer, we hold an amazing beach retreat in Sardinia, Italy!
  • Free lunch - yes, being in Italy, it's something you should care about!
  • Organic fresh fruit
  • Your personal MacBook
  • Flexible work hours
  • Free, superior Italian coffee - of course
  • Free cookies, if you deserve them
  • Much more...

Benefit

A Unique & Extraordinary Team

A Unique & E...

Competitive Salary

Competitive ...

Free Lunch & Cookies!

Free Lunch &...

Massages

Massages

Personal Development Support

Personal Dev...

CLOSED VACANCY Apply now

Video