Senior Regulatory Affairs Specialist - Remote MedTech & SaMD

OrganOx Limited; Atlanta (GA); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision

401(k) with company match

Paid time off

Holidays

Wellness facilities

Professional development

Job summary

OrganOx is a global medical device company focused on organ technology. The Senior Regulatory Affairs Specialist will lead regulatory submissions for North America, support ISO/GMP compliance, and collaborate with R&D, Manufacturing and QA to advance OrganOx products.

The role is flexible remote or hybrid on-site in Madison, NJ with up to 5% travel. Ideal candidates have 3–8 years in regulatory affairs for Class II/III devices and SaMD/SiMD.

Qualifications

• Bachelor’s degree in engineering, life sciences or related field.
• 3–8 years regulatory experience for Class II/III medical devices and SaMD/SiMD.
• RAC (optional).
• Able to travel up to 5% domestically or internationally.

Responsibilities

• Provide regulatory affairs support for Digital Health, Software, Cybersecurity, and electromechanical devices.
• Support pre-market and post-market regulatory activities for assigned projects.
• Collaborate with cross-functional teams to provide regulatory support.
• Prepare regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada.
• Interface with the FDA and Health Canada on assigned projects.
• Respond to FDA and Health Canada requests for additional information.
• Keep abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes.
• Formally communicate regulatory initiatives or changes in the applicable medical device law with company personnel and stakeholders.
• Perform regulatory change assessments as required.
• Review applicable regulatory guidance and standards for assigned projects to ensure compliance.
• Prepare visualizations and conclusions for presentation to upper management.
• Work with key stakeholders on Regulatory topics.
• Adhere to OrganOx Code of Conduct and policies.

Skills

FDA processes

SaMD/SiMD/Cybersecurity

Class II/III devices

Regulatory strategy writing

GMP knowledge

Cross-functional collaboration

MS Office

Technical writing

Independent work

Education

Bachelor’s degree in engineering or life sciences

Regulatory Affairs Certification (RAC) (Optional)

Job description

OrganOx is a global medical device company focused on organ technology. The Senior Regulatory Affairs Specialist will lead regulatory submissions for North America, support ISO/GMP compliance, and collaborate with R&D, Manufacturing and QA to advance OrganOx products.

The role is flexible remote or hybrid on-site in Madison, NJ with up to 5% travel. Ideal candidates have 3–8 years in regulatory affairs for Class II/III devices and SaMD/SiMD.