Manager, Regulatory AffairsAugust 30, 2021 2021-09-06 10:57
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
We are looking for a passionate and ambitious Regulatory Affairs Manager (Digital Health) to join us in the bold and transformational journey to improve mental health, physical health, and wellbeing across the continuum of care. We are seeking a candidate who is analytical, strategic thinker, comfortable working in a fast-paced environment with a proven ability to be agile and embrace areas of ambiguity.
The primary responsibilities will include leading and representing regulatory on new product development team and collaboratively work with various functions (including but not limited to software, marketing/research, R&D, clinical, and quality) in implementing innovative regulatory strategy for digital therapeutics (DTx)/ Prescription Digital Therapeutics (PDTs) and manage overall life-cycle management of products. You will also work closely with clinical affairs to drive regulatory submissions (FDA Pre-Submission, 510(k), 5139g), De Novo, etc.) for claims expansions on products using real-world evidence (RWE). Finally, you will be accountable for direct interactions with FDA and international regulatory bodies, timely submissions to relevant health authorities. #LI-Remote
- Lead/represent regulatory on project core teams (new product development, software development, obsolescence, new suppliers, etc.) to provide regulatory input on all matters.
- Prepare regulatory strategies, assessments and submissions for US, EU, and other international markets.
- Maintain a strong grasp of regulatory guidance and trends in the areas of PDT/Digital Health/SaMD and ensure that information is disseminated across to relevant stakeholders for effective decision making as it relates to developing regulatory strategies and associated submissions.
- Conduct training programs to educate employees on regulatory processes and requirements.
- Assess product, software development and labeling changes for regulatory reporting and review marketing and sales materials for compliance to regulations.
- A bachelor’s degree and a minimum of 5 years of related experience OR an advanced degree (M.S., M.E., Ph.D. or M.D.) and a minimum of 3 years of related experience.
- Experience (including submissions) with Class II (US) and Class II/III (EU).
- Experience with Class II (US) and Class II/III (EU) SaMD is preferred.
- Demonstrated track record of developing and executing US and International regulatory strategies and successful submissions that align with business deliverables.
- Sound knowledge of SaMD US FDA digital health regulations – requirements and familiarity with 21st Century Cures Act.
- Strong people leadership ability with a focus on mentoring and developing talent and program management experience.
- Experience and familiarity with Quality Management System (QMS), Design History File (DHF), ISO 13485, 14971, 62366, 62304 and other relevant regulatory guidance documents.
- Experience working and negotiating with regulatory bodies.
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.