Job Description

About Zywie

Founded in 2014, 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. That’s where you come in.

The Opportunity

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.

What You’ll Do

• 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

What You’ll Bring

• 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
• 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
• 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

Competencies

• Meaningful Innovation
• Ownership & Accountability
• Pace & Efficiency
• Teamwork & Collaboration
• Integrity & Ethical Practice
• Resilience & Grit

Compensation & 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

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Zywie is an Equal Opportunity Employer. Zywie does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.