Senior Regulatory Affairs Specialist (MedTech)

TL;DR

Senior Regulatory Affairs Specialist (MedTech): Developing and executing global regulatory strategies and managing product submissions for orthopedic enabling technologies with an accent on hardware and Software as a Medical Device (SaMD). Focus on securing marketing authorizations in US, EU, and Australian markets, integrating AI/ML capabilities, and ensuring compliance with ISO and FDA standards.

Location: Austin, TX. Applicants must have full-time work authorization in the United States; no sponsorship (e.g., H-1B) is provided.

Company

Innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that improve patient outcomes in orthopedics.

What you will do

• Develop global regulatory strategies for new product development to identify streamlined pathways for marketing authorization.
• Prepare and execute regulatory submissions and technical documentation for the US (FDA), EU (MDR), and Australia (TGA).
• Collaborate with clinical affairs to develop and execute clinical strategies and investigations necessary for authorizations.
• Act as the regulatory SME on product development teams, providing guidance on predicate identification, validation testing, and risk management.
• Review labeling, marketing collateral, and QMS change orders to ensure global regulatory compliance and safety.
• Manage regulatory-related CAPAs and support the Corporate Shared Services team with field actions and recalls.

Requirements

• Bachelor’s degree in science, biomedical engineering, regulatory affairs, or a related field.
• 7–8 years of experience in Regulatory Affairs within the medical device or healthcare industry.
• Proven expertise in US, EU, and TGA regulations, including ISO 13485, ISO 14971, and MTAA Code of Practice.
• Experience preparing 510(k) submissions and Technical Documentation.
• Must already possess full-time work authorization in the United States without requiring sponsorship.

Nice to have

• Experience working with products utilizing machine learning and/or artificial intelligence.
• Experience with international regulatory submissions beyond the primary US, EU, and Australian markets.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan and spending/savings accounts.
• Paid vacation, sick leave, and holidays.
• Income protection plans and discounted insurance rates.
• Professional legal services.