Flo’s enjoyed strong growth in the last few years having more than doubled in headcount and valuation. As we continue to expand our products and services towards IPO, we aim to diversify our product portfolio by including features that would fall under medical device regulations, such as contraception and conception products.

It’s a senior role, responsible for providing strategic regulatory advice to the CLO and Chief Medical Officer, company’s executives, and Board of Directors. The role is expected to create and implement regulatory strategy for the company and guide the company in its journey to certify some of its features as medical devices.

Must have experience:

• Over 10 years of regulatory affairs experience in the medical device domain (with a focus on FDA and EU MDR);
• Medical, legal, regulatory or similar education relevant to the field;
• Experience of successfully bringing consumer SaMD to the market in the US and the EU (class IIa and higher);
• Excellent knowledge of relevant medical device regulations and applicable practice in the EU and US;
• Knowledge of FDA’s ways of working and experience with advocacy with regulatory bodies;
• Experience in building quality management systems compliant with ISO 13485;
• Knowledge of relevant tooling to ensure compliance with ISO 13485;
• Knowledge of the digital health segment and approaches to certification of SAMD;
• Cross-functional project management experience;
• Managerial experience.

What we expect you to do:

Work on the digital contraception project:

• Identify digital contraception algorithms currently available, including the ones developed by the Company
• Evaluate their clinical validity, regulatory status, usability, and potential for clearance with regulatory authorities
• Together with Product and Engineering, refine and develop a product that would be eligible for clearance as a digital contraceptive SaMD in the US/EU
• Support the Science and Medical team on required scientific validation and studies 
• Hire and lead a team of two QARA associates

Regulatory Strategy Development and Implementation

• Lead on the specification of intended use, device description, and risk classification for proposed SaMD
• Hire and line manage team required to achieve milestones/deliverables as per the roadmap
• Lead on submission and pre-submission of the SAMD, including contraception device, to FDA and other relevant regulatory bodies.
• Design a comprehensive training program covering key SaMD regulatory topics in general, and Flo Health’s QMS and technical documentation

Project Management of Development and Submission of Quality Management System (QMS) and Technical File

• • Identify gaps in existing processes and procedures at Flo Health, relative to the requirements of EU MDR, 21 CFR Part 820, ISO 13485, and other applicable regulations and standards
  • Document existing processes, and develop and document additional required processes and procedures.
  • Provide oversight of the creation and review of regulatory documents
  • Support for technical file submissions and QMS compliance

Audit and Inspection Readiness

• • Prepare organisation for internal and external audits, with training and mock audits, required for certification.
  • Arrange the conduct of internal audits and lead on the addressing of findings.
  • Represent the organisation on medical device regulatory issues in external audits, with regulators, and lead on addressing findings