Principal Regulatory Affairs Specialist- Georgia

FloodGate Medical • Tampa, FL

2d • Remote

About The Position

Zywie is a founder-led, privately held remote cardiac monitoring company focused on transforming cardiovascular care. Our main product is the ZywieNano™ MCT Patch, which offers up to 30 days of continuous ECG monitoring and is paired with ZywieAI™, an AI-driven arrhythmia detection platform. We have a significant track record of patient monitoring and clinical notifications and are now entering an exciting growth phase by developing our own proprietary hardware. The Principal Regulatory Affairs Specialist will be the lead regulatory execution expert, responsible for developing and executing regulatory strategies for product development, FDA submissions, and global market access. This role reports to the Sr. Director, Quality & Regulatory Affairs and will independently lead FDA submissions while establishing scalable regulatory processes. The successful candidate will have a significant impact on regulatory strategy, product development, and international expansion, requiring a self-starter with extensive experience in FDA submissions, cross-functional team collaboration, and navigating global regulatory requirements.

Requirements

• RAC (US) certification.
• Experience with Class II software-enabled (specifically AI/ML) medical devices.
• Experience supporting De Novo or PMA submissions.
• Experience in startup or rapidly growing medical device organizations.

Nice To Haves

• Support international product registrations.
• Develop regulatory strategies for EU MDR, Health Canada, UKCA, TGA, and other international markets.
• Coordinate submissions with international regulatory partners and Notified Bodies.

Responsibilities

• 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.
• Independently prepare and submit Traditional 510(k)s, Special 510(k)s, eSTAR submissions, Letters to File, and 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.
• Review product labeling, Instructions for Use (IFU), promotional materials, and marketing claims to ensure compliance with FDA and applicable international regulations.
• Support UDI and device listing requirements.
• Monitor changes in global regulations, standards, and FDA guidance, assessing regulatory impact on existing and future products.
• Recommend process improvements based on regulatory trends.
• 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.
• Develop regulatory procedures and work instructions.
• Maintain regulatory records and submission archives.
• Support implementation of regulatory processes within the eQMS.
• 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.

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

What This Job Offers

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