Senior Quality & Regulatory Specialist

We are looking for a highly skilled and motivated Lead Quality & Regulatory Specialist to support our VP of Regulatory in developing and executing quality assurance and regulatory affairs strategies for Software as a Medical Device (SaMD). This role will play a key part in preparing Flo’s features for regulatory clearance and certification in the US, UK and EU. You will be hands-on across projects, contributing to regulatory planning, documentation, quality system implementation, audit readiness, and cross-functional coordination.

You will work closely with the Science, Product, Engineering, Legal, and Medical teams to ensure regulatory requirements are met while enabling innovation and speed. This is an exciting opportunity to help shape Flo’s regulatory function from the ground up.

What You’ll Be Doing

Regulatory Support & Execution

• Collaborate with the VP of Regulatory to execute regulatory strategy and ensure alignment with business objectives.
• Support the development of intended use statements, qualification & risk classification, and device descriptions for Flo’s SaMD products.
• Prepare and review regulatory documentation required for submissions to FDA (510(k), De Novo) and Notified Bodies (EU MDR).
• Assist in planning and executing pre-submissions, regulatory interactions, and responses to authority feedback.

Quality Assurance & Compliance

• Support the development and implementation of Flo’s QMS in compliance with ISO 13485, 21 CFR Part 820, and EU MDR.
• Draft and maintain standard operating procedures (SOPs), work instructions, and templates.
• Contribute to the preparation of technical documentation for medical device files.

Audit & Inspection Readiness

• Support internal and external audit readiness, including conducting mock audits and training stakeholders.
• Assist in managing corrective and preventive actions (CAPAs) and audit findings resolution.

Cross-Functional Collaboration

• Work with Product, Engineering, Medical, and Science teams to align product development with regulatory requirements.
• Collaborate on clinical evaluation, usability testing, and validation plans for digital contraceptive features.
• Help drive a regulatory culture within the company by supporting internal education and training initiatives.

What You Bring

• 6+ years of experience in regulatory affairs, with strong exposure to SaMD, medical devices, or digital health.
• Proven track record of supporting successful FDA and/or EU regulatory submissions (Class II or higher).
• In-depth knowledge of applicable regulations and standards, including EU MDR, FDA requirements, ISO 13485, ISO 14971 and IEC 62304.
• Strong documentation skills and attention to detail.
• Experience working in fast-paced, cross-functional environments.
• Excellent communication and project coordination abilities.
• A relevant degree in a regulatory, scientific, engineering, legal, or medical field.

Nice to Have

• Experience with quality management system implementation from scratch.
• Familiarity with regulatory tools (e.g., MasterControl, Greenlight Guru).
• Prior experience supporting internal or external audits.
• Passion for women’s health and digital innovation
• Previous experience as a Person Responsible for Regulatory Compliance