Director of Regulatory Affairs & Quality

FloodGate Medical • Tampa, FL

3d • Remote

About The Position

Zywie is a founder-led, privately held remote cardiac monitoring company on a mission to transform cardiovascular care. Our flagship product, the ZywieNano™ MCT Patch — the smallest cardiac monitoring patch on the market — delivers up to 30 days of continuous ECG monitoring paired with ZywieAI™, our proprietary AI-driven arrhythmia detection platform. We have monitored over 500,000 patients, analyzed more than 1 trillion heartbeats, and generated 4.5 million unique clinical notifications. We are profitable, self-funded, and scaling fast — growing our commercial team from 3 to nearly 25 reps in five years. We are now entering the most exciting chapter of our growth: developing and bringing our own proprietary hardware to market. This is a ground-floor build. As Director of Regulatory Affairs and Quality, you will be the first dedicated regulatory and quality leader in Zywie’s history — responsible for architecting the infrastructure that will carry this company through its next phase of growth. You will report directly to senior leadership, work closely with our R&D and CTO teams, and have the autonomy to build, execute, and own the regulatory and quality function from the ground up. This is a Nationwide search — remote with periodic travel to the Johns Creek, GA office approximately 4–5 days per month.

Requirements

• 5–7+ years of regulatory affairs and quality experience in medical devices
• Hands-on 510(k) submission experience with Class II devices — hardware and software a strong plus
• Proven ability to build a QMS independently — not just maintain one
• Strong communication, interpersonal, and problem-solving skills
• A collaborative, practical mindset — someone who knows how to prioritize what matters and work with the business, not against it
• Ability to analyze data, identify trends, and make strategic recommendations
• Ability to work under pressure and manage multiple priorities in a fast-paced environment

Nice To Haves

• Background in cardiac monitoring, cardiology devices, digital health, or SaMD strongly preferred — experience at iRhythm, BioTelemetry, Preventice, Bardy, Cardionet, or LifeWatch is a significant advantage
• Mid-size or growth-stage company experience preferred — we need someone who rolls up their sleeves and does the work, not delegates it
• Working knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820

Responsibilities

• Design and implement a Quality Management System (QMS) from scratch — document control, CAPA, complaint handling, change control, and beyond
• Lead FDA regulatory strategy and submissions — 510(k), Pre-Sub meetings, and ongoing correspondence across both software and hardware product lines
• Own post-market surveillance, MDR reporting, and complaint handling across an active patient base of 500,000+
• Partner closely with R&D and product leadership to advise on design controls, risk management, and DHF development for three devices currently in the pipeline
• Ensure ongoing IDTF certification compliance and HIPAA alignment across our cloud-based platform
• Monitor and interpret evolving FDA guidance on AI-enabled medical devices and SaMD — and translate that into action for the business
• Prepare the organization for FDA inspections and audits
• Build toward ISO 13485 alignment as the company scales toward full device manufacturer status
• Serve as the internal authority on all things regulatory and quality — advising leadership proactively, not reactively
• Possess current knowledge of existing and emerging medical device regulations, directives, standards, and guidance documents (FDA, ISO, EN, MDR, MDD, etc.)
• Review Engineering Change Orders and determine regulatory status and filing requirements
• Review product labeling, promotional material, and marketing literature for regulatory compliance
• Develop and conduct employee training on regulatory and quality requirements
• Establish and manage the regulatory budget

Benefits

• Base salary: $160,000 – $170,000 (flexible to experience)
• Performance bonus | Total compensation target: ~$200,000+
• Full travel reimbursement — flight, hotel, transportation, and daily meal stipend for Atlanta office visits
• Health Insurance
• PTO and Holidays
• 401(k) with company match
• Life Insurance & AD&D Insurance
• Direct access to senior leadership and the opportunity to build something that matters
• A lean, entrepreneurial culture that rewards results and moves fast when the right person is identified

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed