Senior Regulatory Affairs Specialist (AI)

TL;DR

Senior Regulatory Affairs Specialist (Medical Devices/AI): Developing and executing global regulatory strategies for orthopedic hardware and software as a medical device (SaMD) with an accent on FDA, EU MDR, and TGA compliance. Focus on championing regulatory pathways for AI/ML-enabled products, managing product submissions, and ensuring quality standards across international markets.

Location: Must be based in Austin, TX (Onsite)

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that improve patient outcomes and transform healthcare workflows.

What you will do

• Develop global regulatory strategies for new product development and modifications.
• Prepare and manage regulatory submissions (510(k), technical documentation) for US, EU, and Australian markets.
• Act as the regulatory representative on cross-functional product development teams.
• Facilitate regulatory strategies supporting the integration of AI and machine learning in medical products.
• Perform regulatory impact assessments for product changes and manage post-market surveillance activities.
• Liaise with regulatory authorities including FDA, Notified Bodies, and TGA.

Requirements

• Bachelor’s degree in science, biomedical engineering, or regulatory affairs.
• 7–8 years of experience in regulatory affairs within the medical device or healthcare industry.
• Proven expertise in US, EU, and TGA regulations, ISO 13485, and ISO 14971.
• Must have full-time work authorization in the United States without sponsorship.
• Experience preparing regulatory submissions such as 510(k) and technical files.
• Strong analytical, communication, and problem-solving skills.

Nice to have

• Experience working with products incorporating machine learning or artificial intelligence.
• Experience with international regulatory submissions beyond US/EU/Australia.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance plans.
• 401(k) retirement plan with company contributions.
• Paid vacation, sick leave, and holidays.
• Income protection plans and legal services.
• Collaborative environment focused on scientific excellence and patient outcomes.