Senior Regulatory Affairs Specialist — Global Device Submissions (Remote)

Regulatory Jobs; United States; Remote; USD 83,000 - 104,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

Fertility care benefits

401k benefits

Job summary

Natera is seeking a Sr. Regulatory Affairs Specialist to prepare regulatory submissions for medical devices and IVDs in domestic and international markets.

The role develops strategies for FDA filings and ensures regulatory compliance throughout product development, including clinical studies and labeling reviews. You will work with product teams to ensure submissions meet requirements, interact with regulatory agencies, and monitor clinical data to guide decisions.

Qualifications

• Current knowledge of U.S. medical device and IVD regulatory requirements, GLP, and QSR.
• Ability to communicate effectively with all levels of the organization and external partners.

Responsibilities

• Interpret U.S., EU and international regulatory requirements for medical devices and IVDs.
• Guide product development teams on regulatory expectations.
• Develop strategies for FDA submissions and other regulatory agency filings.
• Provide risk assessments and options for regulatory compliance.
• Prepare and compile information for FDA 510(k), PMA, IDE, PDP, and ex-US registrations.
• Coordinate data requests from regulatory agencies and respond appropriately.
• Review labels, labeling, and promotional materials for compliance.
• Ensure training requirements including HIPAA/PHI are completed in a timely manner.

Skills

Regulatory knowledge

Cross-functional communication

Project management

Education

Bachelor's degree in biological sciences/chemistry

Job description

Natera is seeking a Sr. Regulatory Affairs Specialist to prepare regulatory submissions for medical devices and IVDs in domestic and international markets.

The role develops strategies for FDA filings and ensures regulatory compliance throughout product development, including clinical studies and labeling reviews. You will work with product teams to ensure submissions meet requirements, interact with regulatory agencies, and monitor clinical data to guide decisions.