Senior Regulatory Specialist (Medical Devices)

TL;DR

Senior Regulatory Specialist (Medical Devices): Managing regulatory submissions and compliance for orthopedic implants and instruments with an accent on FDA and ISO standards. Focus on preparing pre-market submissions (510(k), PMA), executing CAPAs for regulatory processes, and providing strategic RA support for new product development.

Location: Onsite in Gainesville, FL

Company

hirify.global is an innovation-driven company specializing in developing revolutionary orthopedic implants and surgical instruments to improve patient mobility and outcomes.

What you will do

• Prepare and maintain pre-market and post-market change submissions for a variety of global markets with minimal oversight.
• Provide project-level regulatory strategy and support for new product development and post-market lifecycle projects.
• Serve as the Regulatory Affairs lead member within project teams.
• Assess and approve product and process nonconformances, deviations, and post-market changes.
• Own and execute CAPA for regulatory processes.

Requirements

• Bachelor’s Degree from an accredited institution.
• Minimum 5 years of experience in FDA/ISO medical devices quality management system (QMS) standards.
• 5 years of experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations.
• Proficiency in technical writing.
• Must be based in or able to work onsite in Gainesville, FL.

Culture & Benefits

• Environment focused on continuous innovation and cutting-edge technology.
• Work on products that directly transform patient mobility and freedom.
• Collaborative approach to improving surgical experiences and efficacy.