Regulatory Affairs Advisor

Natera seeks a Regulatory Advisor to lead FDA Pharma and IVDR regulatory strategy for genetic testing and liquid biopsy products. The role involves developing submission strategies, managing regulatory interactions with authorities, and mentoring team members in a remote position focused on diagnostic innovation.

Responsibilities

• Develop and execute regulatory strategies for FDA Pharma, IVDR, and IVD submission programs
• Prepare and coordinate regulatory submissions including 510(k)s, technical documentation, and worldwide registrations
• Conduct stakeholder communications with regulatory authorities regarding pathways, claims, and labeling
• Mentor regulatory associates and deliver training on regulatory topics across teams
• Assess product changes for global regulatory impact and ensure promotional compliance

Requirements

• Expertise in FDA regulations, IVDR, CAP/CLIA, and diagnostic device classification
• Experience preparing 510(k) submissions, IVD technical documentation, and pre-submissions
• Strong knowledge of regulatory pathways for in vitro diagnostic systems and pharma approvals
• Demonstrated ability to represent regulatory function with internal and external stakeholders
• Experience mentoring regulatory staff and leading cross-functional compliance initiatives