Regulatory Product Development Specialist
Operations • Boston, Massachusetts, United States • Full time

Description

Empatica

We are a digital healthcare company specialized in building AI systems to monitor people’s health. Since 2013, we have been making beautifully designed wearables, software platforms and tools, and advanced algorithms, unlocking better health outcomes for thousands of people.

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.

The role

In the Regulatory and Quality Team, we are responsible for maintaining the company Quality Management System, and related product and system certification, develop regulatory strategies that ensure products compliance with the applicable regulatory requirements, support internal stakeholders in ensuring compliant workflows, as well as supporting management in the optimisation of internal workflows.

As a Regulatory Product Development Specialist you will be a key member of the team, supporting new product development and 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:

• Develop and establish policies and standards that convey the best practices in the company
• Create instructions for use, consent forms, case report forms and other documents in collaboration with other cross-functional team members
• Keep up-to-date with changes in regulatory legislation and guidelines, read/interpret scientific and medical literature for use in clinical documents and assist in clinical team decisions
• Prepare and review documentation for FDA, according to overall company strategy
• Support Research and Development teams by providing regulatory guidance to ensure compliance through all stages of new product development and entry into new markets

Requirements

What we are looking for

• As the ideal candidate for this position you:
• Are a native English speaker
• Have a strong academic background, BS or MS in Computer Science or Electrical Engineering is a plus
• Have at least 5 years experience as a Documentation Specialist or Technical Writer preferable in a company that designs/manufactures medical devices,  wearable devices or IoT devices
• Have strong knowledge and experience working with ISO standards and FDA 510(k) clearance process
• Have past experience with privacy policy, experience with GDPR 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 Empatica

You 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 Regulatory Product Development 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.

Benefits

• Competitive salary
• The position is based at our Boston HQ. We also have an office in Milan, plus an amazing beach summer retreat in Sardinia, Italy!
• MacBook
• Flexible work hours
• Free cookies, if you deserve them 😛
• Much more…

At Empatica, we support the personal and professional growth of our employees. Beyond the above, you’ll have the possibility to attend conferences, receive dedicated training, and participate in activities relevant to where you want your career to go.

Please click here to apply.