Regulatory Affairs SpecialistAugust 30, 2021 2021-09-02 19:50
About Happify Health
Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people. The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.
Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.
About the Role
As a Regulatory Affairs Specialist, you will join the compliance team in blazing the trail when it comes to the regulatory landscape for Digital Therapeutics. We are looking for passionate and mission driven individuals who strive to develop safe, effective, and novel digital products that can be made available to the public.
The primary responsibilities for this role include performing regulatory assessments across a diverse range of digital products and assisting in developing cutting edge strategies regarding digital therapeutics and prescription devices. You will take software industry-accepted Good Manufacturing Practices and adapt them to regulatory frameworks for medical devices. You will ensure that the complete software development life cycle has been realized through both premarket development and postmarket phases of digital products to support submissions and auditing activities from regulatory authorities. #LI-REMOTE
- Assist in building device submission packages to various regulatory authorities.
- Understand the current regulatory guidelines regarding cybersecurity and usability of Software as a Medical Devices (SaMD) to help drive device submission strategies.
- Perform regulatory intelligence analysis regarding updates in guidances and regulations for digital medical devices.
- Be a subject matter expert (SME) of US and EU medical device regulations to enforce adherence to SOPs and to continuously improve Quality Management Systems (QMS).
- Maintain device history files through post-market phases of development.
- Drive product development and clinical affairs teams to perform adequate risk assessments of products in development.
- Bachelor’s degree and 3+ years of experience in medical device regulatory affairs.
- Digital health, healthcare/wellness, or related product experience preferred.
- Experience in risk management and perform risk classification assessments of medical devices.
- Excellent communication skills with the ability to work with cross-departmental teams consisting of engineering, marketing, research teams, and clinical affairs.
- Previous experience in performing device submissions and interfacing with FDA reviewers.
- Experience with medical device clinical trials.
- Background in software development GMP and/or device cybersecurity.
- Sound understanding of medical device standards including ISO 13485, ISO 14971, IEC 62304, ISO 27001, 21 CFR 820, and MDR.
- Ability to thrive in a fast-paced, technical, and mission-focused environment.
- HIPAA, and GDPR knowledge are a plus.
- RAC certification is a plus.
Happify values candidates with different backgrounds, experiences, and perspectives. We do not discriminate based upon ethnicity, age, gender identity and expression, sexual orientation, religion, national origin, socioeconomic status, disability, or veteran status. We’re committed to building a company that is an inclusive environment for all.
To apply for this job please visit boards.greenhouse.io.