VP of Regulatory

Job Description

Flo, a leading health app with over 400M downloads and 75M monthly users, is seeking a VP of Regulatory to provide strategic regulatory advice and guide the company in certifying features as medical devices. This role involves working on digital contraception projects, developing and implementing regulatory strategies, and managing the development and submission of a Quality Management System (QMS) and technical file.Flo has experienced strong growth and is preparing for a potential IPO, aiming to diversify its product portfolio with features falling under medical device regulations.Responsibilities:

• Work on digital contraception projects, evaluating algorithms and refining products for clearance as a digital contraceptive SaMD in the US/EU.
• Lead the specification of intended use, device description, and risk classification for proposed SaMD.
• Lead on submission and pre-submission of the SAMD to FDA and other relevant regulatory bodies.
• Design a comprehensive training program covering key SaMD regulatory topics.
• 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.
• Prepare the organization for internal and external audits, with training and mock audits, required for certification.

Requirements:

• 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 Flo offers:

• Competitive salary and annual reviews.
• Opportunity to participate in Flo’s performance incentive scheme.
• Paid holiday, sick leave, and female health leave.
• Enhanced parental leave and pay for maternity, paternity, same-sex and adoptive parents.
• Accelerated professional growth through world-changing work and learning support.
• Flexible office + home working, up to 2 months a year working abroad.
• 5-week fully paid sabbatical at 5-year Floversary.
• Flo Premium for friends & family, plus more health, pension and wellbeing perks.