Quality Assurance and Regulatory Affairs Specialist
Empatica, Italy
Job Description
Our customers range from some of the world’s largest institutions to individual users who message us every day and tell us how our products changed their lives. Our newest wearable, EmbracePlus, is sponsored by NASA and will be used to monitor the health of the astronauts onboard the first ever manned mission to Mars. Pharmaceutical companies are using our research platform to fast-track the development of new treatments, while hundreds of academic researchers publish new discoveries on human behavior weekly, all made possible by our E4 smartband and software tools. And we just partnered with the US’ Department of Health and Human Services to accelerate the release our wearable COVID-19 early detection system.
If you are looking to join a fast-paced growth environment and do meaningful work that can really make a change in people’s lives, keep reading.
As a Quality Assurance amp; Regulatory Affair Specialist you will be a key member of the team, supporting the maintenance of the Quality Management System, serve as regulatory and quality representative in product development team, proposing improvements to internal systems, and providing advice on regulatory requirements.
In addition, working together with other internal teams including Operations, Business development, Hardware, Data, Software, and Firmware development you will:
- Maintain Empatica’s Quality Management System up to date
- Perform Internal Audit
- Create instructions for use, consent forms, case report forms and other documents in collaboration with other cross-functional team members
- Support Research and Development teams by providing regulatory guidance to ensure compliance through all stages of new product development and entry into new markets
- Support the validation effort of product and precesses within Empatica
Requirements
What we are looking forAs the ideal candidate for this position you:
- Are a native English speaker or proficient in English
- Have a strong academic background, BS or MS in Biomedical Engineering or Regulatory Affairs
- Have at least 2 years experience as a Quality Specialist or Regulatory Affairs specialist preferable in a company that designs/manufactures medical devices, wearable devices or IoT devices
- Have knowledge and experience working with ISO standards and FDA 510(k) clearance process
- Have past experience with privacy policy, experience with GDPR and clinical evaluation is a plus
You and Empatica would be a perfect match if you are:
- A very quick learner
- Fun and easy to work with
- A hard-worker and collaborative
- A doer, with an excellent execution mindset
- An outstanding planner, with excellent time management and multitasking skills
- Focused on quality and excellence
- Flexible in terms of working time and ability to travel
- A problem-solving hustler who can take on any big or small project
- Passionate about our products and our mission
Life at EmpaticaYou will join a fast-growing, diverse team of 70+ brilliantly talented humans, who care passionately about what we do and the difference we are making in the world. You’ll get the opportunity to work directly with engineers, data scientists, and designers, across all levels of the organization.
At Empatica, we believe in a work environment that fosters autonomy, mastery, and purpose. We also believe in flexibility, so you will have the opportunity to work remotely in this position.
All you need to do is show us that you have skills and that you are a team player. Once you join our team as a Quality Assurance and Regulatory Affairs Specialist, you will have full control of your schedule and can decide when you'll work from the comfort of your home or when you'll prefer to mingle with your awesome team members in the office.
If you jump on board, we can guarantee it won't be an easy ride, but it will be one of the most rewarding experiences in your career, one that will allow you to learn a lot and test your whole skill-set on multiple projects, which are already helping thousands of people worldwide.
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