Senior Regulatory Affairs Specialist – SaMD/SiMD, Remote

OrganOx; Madison (NJ); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Holidays

Employee discounts

Job summary

OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs, PMAs, and PMA supplements.

The role supports regulatory change assessments, keeps abreast of standards, and may involve domestic and international travel. A Bachelor's degree in engineering or life sciences is required.

Qualifications

• Experience with FDA regulatory processes for medical devices and SaMD/SiMD.
• Familiarity with Class II/III device submissions and approvals.
• Ability to craft regulatory strategies and submissions clearly.
• Understanding GMP and quality systems in medical device contexts.
• Proven cross-functional collaboration across Manufacturing, Quality, R&D, Clinical and Marketing.

Responsibilities

• Prepare regulatory submissions (FDA/Health Canada) including IDEs/PMAs and supplements.
• Support pre-market and post-market regulatory activities for assigned projects.
• Interface with FDA/Health Canada and respond to information requests.
• Monitor changes in US/Canada regulatory requirements and ISO standards.
• Provide regulatory guidance to cross-functional teams and management.

Skills

FDA regulatory knowledge

SaMD/SiMD/Cybersecurity

Class II/III devices

Regulatory strategy writing

GMP awareness

Cross-functional collaboration

Independent work

MS Office

Education

Bachelor's degree in engineering or life sciences

Tools

MS Office

Job description

OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs, PMAs, and PMA supplements.

The role supports regulatory change assessments, keeps abreast of standards, and may involve domestic and international travel. A Bachelor's degree in engineering or life sciences is required.