About Happify Health
Happify Health is a global software-enabled healthcare platform focused on improving mental and physical health. Our platform utilizes an evidence-based approach that delivers scientifically-validated programs which positively impact behavior to help manage chronic conditions alongside providing access to solutions such as telehealth, AI-powered coaching and access to therapeutics, as required, to improve peoples’ everyday lives. Happify Health offers two core solutions for its customers and end-users; Digital Therapeutics and Care Delivery solutions and services across the healthcare ecosystem, including enterprises, health plans, health systems, pharmaceutical manufacturers, and individuals. Today, the Happify Health platform is available globally in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives.
About the Role
The Regulatory Affairs Manager will focus on helping the company with the development and clearance of their novel digital therapeutics’ devices, and combination products through all stages of regulated development. You will prepare global regulatory documents and submissions. You will formulate, lead, and implement innovative regulatory strategies based on key stakeholders input (stated goals, corporate objectives, and risk tolerance), their experience with the regulatory, medical and commercial environment, and through strong teamwork with colleagues and partners. Finally, you will be accountable for direct interactions with FDA and international regulatory bodies, timely submissions to health authorities.
- Establish Regulatory Affairs project priorities, ensuring that resources are available and balanced.
- Lead/represent on project core teams (new product development, software development, obsolescence, new suppliers, etc.) to provide regulatory input on all matters.
- Prepare regulatory plans and prepare needed regulatory submissions and associated documents for FDA, Health Canada, Notified Bodies, and ROW countries and secure approvals.
- 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.
- Maintain company registration and device listings for global regulatory agencies.
- 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 global regulatory strategies that align with business deliverables.
- Strong people leadership ability with a focus on mentoring and developing talent.
- Experience working and negotiating with regulatory bodies.
- Ability to thrive in a fast-paced, technical, and mission-focused environment.
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.
There have been cases of scams targeting candidates by individuals pretending to work at Happify. We will never ask you to share financial information to participate in our recruiting process. If you suspect that you've been contacted by a scammer, please consider filing a report with law enforcement. If you'd like to verify an email you received from Happify, please write us at email@example.com.