Senior Regulatory Affairs Specialist - Medical Devices (FDA focus)

TL;DR

Senior Regulatory Affairs Specialist - Medical Devices (FDA focus): Lead U.S. regulatory strategy and compliance for medical device submissions, with an accent on 510(k) application planning, FDA liaison work, and regulatory impact of design changes. Focus on building submission documentation, coordinating Pre-Sub meetings, and maintaining Quality Management System compliance while managing post-market safety complaints.

Location: Sarasota, FL

Salary: $79,380–$118,600 annually

Company

hirify.global builds engineered components and sub-systems for healthcare and advanced manufacturing.

What you will do

• Develop and execute FDA regulatory strategies, including preparation and submission of 510(k) applications and related documentation.
• Monitor regulatory developments (FDA guidance, 21 CFR) and compile other approval-relevant documents (e.g., free sales certificates, legalizations, declarations, certificates).
• Serve as primary liaison with the FDA and other regulatory authorities, coordinating Pre-Sub meetings and tracking regulatory changes.
• Evaluate design changes for regulatory impact and ensure compliance with design control and change management processes.
• Support audits and inspections with customers, notified bodies, and external partners.
• Manage safety-related complaints and post-market surveillance activities in collaboration with Medical Affairs; maintain and improve the Quality Management System.

Requirements

• 5+ years of related experience.
• Bachelor’s degree.
• Advanced training: “Manager Regulatory Affairs for Medical Devices”.
• Experience preparing and managing FDA submissions, including 510(k); ideally also PMA applications.
• Ability to travel up to 10% to NOVT locations and business partners.

Culture & Benefits

• Full-time role with a full range of medical, financial, and other benefits.
• Salary range provided; potential performance-based incentive compensation and/or long-term incentives may apply.
• Equal employment opportunity and affirmative action workplace.