Senior International Regulatory Affairs Specialist (Medtech)

TL;DR

Senior International Regulatory Affairs Specialist (Medtech): Driving global market access for innovative hardware and software medical devices with an accent on regulatory strategies and high-quality submissions for APAC, MEA, and LATAM. Focus on translating EU MDR requirements into actionable plans and aligning regulatory expectations with fast-paced product development cycles.

Location: Hybrid (Burlington, MA or New York City, NY). Must be legally authorized to work in the US without sponsorship.

Salary: $90,000 - $100,000

Company

hirify.global is driving a digital revolution in ultrasound imaging using proprietary Ultrasound-on-Chip semiconductor technology and AI-powered software solutions.

What you will do

• Execute global regulatory strategies for Class II and higher medical devices, including Software in a Medical Device (SiMD).
• Coordinate international regulatory submissions and registrations across APAC, MEA, LATAM, and MDSAP-participating countries.
• Prepare and manage regulatory documentation, maintaining product registrations and renewals in accordance with country-specific requirements.
• Ensure full compliance with global frameworks, specifically EU MDR 2017/745 and other applicable standards.
• Collaborate with R&D, Quality, Clinical, and Product teams to align regulatory needs with release timelines.
• Assess regulatory impact of product changes and manage actions through established change control processes.

Requirements

• Bachelor's degree in a scientific or engineering discipline (advanced degree preferred).
• 5+ years of progressive regulatory affairs experience in the medical device industry (Class II or higher).
• Proven track record with SiMD and SaMD, including hands-on experience in MDSAP, APAC, MEA, and LATAM regions.
• Strong working knowledge of EU MDR 2017/745 and standards such as ISO 13485, ISO 14971, and IEC 62304.
• Experience operating within a Quality Management System (QMS) including change and design control.
• Legal authorization to work in the United States without current or future visa sponsorship is required.

Nice to have

• Experience in Artificial Intelligence/Machine Learning (AI/ML).
• Regulatory Affairs Certification (RAC).

Culture & Benefits

• Comprehensive health, dental, and vision insurance with annual HSA contributions.
• 401k plan with company match and eligibility for Employee Stock Purchase Plan (ESPP).
• Unlimited Paid Time Off plus 10 fixed holiday days per year.
• Equity stakeholdership and competitive salaried compensation.
• Parental leave and a comprehensive Employee Assistance Program for emotional health.