Autonomous Regulatory Affairs Lead Remote

Hmixray; Somerville (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A medical technology company in Somerville is looking for a Sr. Regulatory Affairs Principal. This role involves developing regulatory strategies for high risk FDA Class III products, leading submissions and ensuring compliance with global regulations. Candidates should have a strong background in regulatory affairs with 13-17 years of experience in a regulated environment. This position offers the flexibility to work remotely and requires excellent communication and leadership skills.

Qualifications

• 13 – 17 years working in a regulated industry, preferably FDA.
• Experience with US FDA Class III devices.
• Knowledge of Medical Devices Regulations (MDR) and ISO standards.

Responsibilities

• Develop regulatory strategy for FDA Class III devices.
• Lead regulatory submissions and manage compliance.
• Provide regulatory input on product lifecycle planning.

Skills

FDA Quality System Regulations knowledge

Regulatory filing experience

Excellent written and oral communication

Education

Bachelor’s degree in life science or engineering

Advanced degree or Regulatory Affairs Certification

Tools

Regulatory submission systems

Job description

A medical technology company in Somerville is looking for a Sr. Regulatory Affairs Principal. This role involves developing regulatory strategies for high risk FDA Class III products, leading submissions and ensuring compliance with global regulations. Candidates should have a strong background in regulatory affairs with 13-17 years of experience in a regulated environment. This position offers the flexibility to work remotely and requires excellent communication and leadership skills.