Quality Systems & Regulatory Affairs Specialist, Digital Health

Who you are

You have experience in regulatory affairs and quality systems, particularly in the digital health sector. You understand the complexities of regulatory compliance and have a knack for creative problem-solving. Your ability to adapt to changing environments is a key strength, allowing you to navigate the dynamic landscape of health technology effectively. You are detail-oriented and possess strong analytical skills, enabling you to execute regulatory strategies with precision. You thrive in collaborative settings, working closely with cross-functional teams to ensure compliance and quality standards are met. Your communication skills are excellent, allowing you to articulate regulatory requirements clearly to both technical and non-technical stakeholders.

Desirable

Experience with Software as a Medical Device (SaMD) regulations is a plus. Familiarity with quality management systems (QMS) and their maintenance will enhance your effectiveness in this role. A background in health technology or a related field will be beneficial, as will any certifications in regulatory affairs or quality management.

What you'll do

In this role, you will be a core member of the Digital Health team at WHOOP, executing regulatory strategies that align with the company's mission to enhance human performance and health span. You will support the maintenance of quality management systems, ensuring that all products meet regulatory standards. Your responsibilities will include preparing and submitting regulatory documentation, conducting audits, and collaborating with product development teams to integrate compliance into the design process. You will also monitor changes in regulations and industry standards, adapting strategies as necessary to maintain compliance. Your role will involve problem-solving and critical thinking to address any regulatory challenges that arise, ensuring that WHOOP's products are safe and effective for users.

What we offer

WHOOP offers a dynamic work environment where innovation is encouraged. You will be part of a mission-driven team focused on improving health outcomes through technology. The company provides opportunities for professional development and growth, allowing you to expand your skills in regulatory affairs and quality management. You will have access to resources and support to help you succeed in your role. Additionally, WHOOP values work-life balance and offers competitive compensation packages to its employees.