Principal Regulatory Affairs Specialist- Georgia

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

The Principal Regulatory Affairs Specialist will serve as the company's lead regulatory execution expert and will be responsible for developing and executing regulatory strategies that support product development, FDA submissions, and global market access.

Reporting to the Sr. Director, Quality & Regulatory Affairs, this individual will independently lead FDA submissions while helping establish scalable regulatory processes and policies. As one of the first Regulatory professionals in the organization, the successful candidate will have significant influence on regulatory strategy, product development decisions, and future international expansion.

The ideal candidate is a self-starter with extensive experience preparing FDA submissions, working directly with cross-functional development teams, and navigating evolving global regulatory requirements.

What You’ll Do 

• Regulatory Strategy

• Develop regulatory strategies supporting product development and commercialization. 

• Evaluate regulatory pathways for new products and product changes. 

• Interpret FDA guidance documents, standards, and evolving regulatory expectations. 

• Provide regulatory guidance to engineering and product development teams throughout development. 

• FDA Submissions

• Independently prepare and submit: 

• Traditional 510(k)s 

• Special 510(k)s 

• eSTAR submissions 

• Letters to File 

• Q-Submissions 

• Coordinate submission content across Engineering, Clinical, Quality, Human Factors, Software, and Risk Management teams. 

• Manage FDA interactions throughout the review process. 

• Develop responses to FDA Additional Information (AI) requests. 

• Labeling & Claims

• Review product labeling, Instructions for Use (IFU), promotional materials, and marketing claims. 

• Ensure labeling complies with FDA and applicable international regulations. 

• Support UDI and device listing requirements. 

• Regulatory Intelligence

• Monitor changes in global regulations, standards, and FDA guidance. 

• Assess regulatory impact on existing and future products. 

• Recommend process improvements based on regulatory trends. 

• Product Development Support

• Participate in Design Reviews. 

• Review Design History Files for regulatory compliance. 

• Support Design Verification, Validation, Clinical Evaluation, and Human Factors documentation. 

• Ensure regulatory requirements are incorporated into product development activities. 

• Regulatory Systems

• Develop regulatory procedures and work instructions. 

• Maintain regulatory records and submission archives. 

• Support implementation of regulatory processes within the eQMS. 

• Cross-Functional Collaboration

• Partner with Engineering, Clinical Affairs, Marketing, Quality, and Executive Leadership. 

• Represent Regulatory Affairs during customer audits and FDA inspections. 

• Mentor future Regulatory Affairs personnel as the organization grows. 

What You’ll Bring

Compensation & Benefits

• Competitive base salary plus performance bonus, commensurate with experience
• 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