Risk Management Specialist

We are looking for a Risk Management Specialist to join our team. In this role, you will take the lead in identifying, assessing, and mitigating risks across Remepy’s operations, with a focus on our FDA-regulated digital therapeutics platform. You’ll play a key role in ensuring that our systems, data, and processes meet the highest standards of integrity, availability, and confidentiality. This includes developing and managing risk assessment frameworks, supporting regulatory compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), and embedding proactive risk management into engineering, product development, and operational workflows. You will collaborate closely with teams across engineering, product, compliance, and leadership to ensure that risk-informed decision-making is built into the foundation of everything we do.

Location

NYC

Work Environment

This role is based in our NYC office offering the opportunity to collaborate closely with our dynamic team in person.

Responsibilities

Own the enterprise risk management framework across software, clinical, and operational domains.
Lead ISO 14971‑compliant risk analyses, FMEAs, and maintain comprehensive risk registers.
Collaborate with Quality, Security, Clinical, and Regulatory teams to implement mitigations.
Prepare documentation for audits, inspections, and regulatory submissions.
Continuously monitor emerging risks and update controls accordingly.

Qualifications

Experience

5+ years of risk management in medical device, pharma, or digital health.
Deep knowledge of ISO 14971, IEC 62304, ISO 27001, and HIPAA requirements.
Proven experience facilitating cross‑functional risk workshops and producing clear documentation.
Analytical mindset with strong attention to detail.
Excellent communication skills in English (written and verbal).

Benefits

Join a purpose-driven startup focused on improving patient outcomes.
Collaborate with experts in healthcare, neuroscience, game design, and technology.
Make a meaningful impact on the lives of patients and their families.

If you’re ready to combine your passion for healthcare and technology, we’d love to have you on our team! 🌟📱🎮

Apply now