Remote Senior Regulatory Affairs Lead – AI Medical Devices

Hmixray; Somerville (MA); Remote; USD 90,000 - 120,000; Full time

Job summary

A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive experience in a regulated environment, and strong communication skills. This position is remote and requires some travel. Competitive salary and benefits offered.

Qualifications

• 8-12 years of experience in a regulated industry, especially related to FDA.
• Knowledge of Medical Devices Regulations and ISO standards.
• Experience drafting regulatory filings for Software as a Medical Device.

Responsibilities

• Provide regulatory guidance on product lifecycle planning.
• Prepare and review regulatory submissions for authorities.
• Ensure compliance with product post-marketing requirements.

Skills

Strong knowledge of FDA Quality System Regulations

Excellent written and oral communication skills

Experience with US FDA Class I and II medical devices

Education

Bachelor’s degree in relevant field

Tools

Regulatory submissions

Technical documentation

Job description

A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive experience in a regulated environment, and strong communication skills. This position is remote and requires some travel. Competitive salary and benefits offered.