Regulatory Affairs Specialist (Medtech)

TL;DR

Regulatory Affairs Specialist (Medtech): Developing and implementing regulatory strategies for new medical device product development with an accent on EU MDR compliant technical documentation and global submissions. Focus on ensuring compliance with FDA, TGA, and Health Canada regulations through the preparation and submission of technical files.

Location: Dallas, Texas, USA. Applicants must already have full-time work authorization in the United States; sponsorship (e.g., H-1B) is not provided.

Company

hirify.global is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that improve patient outcomes in orthopedics and beyond.

What you will do

• Develop and implement regulatory strategies for new product development projects and processes.
• Prepare EU MDR compliant technical documentation and manage global product submission activities.
• Represent the company with US, EU, and international regulators during submission reviews and approvals.
• Define regulatory requirements and provide guidance to cross-functional teams on agency expectations.
• Maintain regulatory documentation in accordance with quality system requirements and support audits and CAPAs.

Requirements

• BS degree in Science or Engineering.
• 1–3 years of experience in Global Regulatory Affairs or the medical device industry.
• Proven experience with EU CE Mark, 510(k), Health Canada, and international market submissions.
• Working knowledge of ISO standards, GMP, Medical Device Regulations (MDR), FDA, and TGA.
• Full-time work authorization in the United States without requiring sponsorship.
• Excellent proficiency in Business English and French.

Nice to have

• Extensive experience with FDA, Health Canada, and TGA submissions.
• Ability to thrive in a deadline-sensitive, high-pressure environment.

Culture & Benefits

• Culture of continuous improvement, innovation, and global talent.
• Collaborative environment working within a cross-functional new product development team.
• Commitment to equal employment opportunities based on merit and experience.