Regulatory Affairs Strategy Lead

POSITION SUMMARY

Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services.

Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line. May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities. Supports overall effectiveness of the regulatory affairs team at Natera through contributions to staff development, process improvements and understanding of current regulatory requirements.

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PRIMARY RESPONSIBILITIES

Strategy & Submissions

• Develops and executes aggressive strategies weighted with realistic regulatory objectives for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.).

• Coordinates and prepares regulatory submissions with minimum supervision, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical registrations worldwide.

• Advocates least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements.

• Conducts business interactions with customers and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including advertising and promotional materials) in the context of submissions or registrations.

• Evaluates product changes for impact to regulatory submissions globally.

• Reviews and ensures regulatory compliance of advertising, promotion and labeling across a common product line.

Leadership & Team Support

• Represents the function on designated teams and may represent RA in different core teams and change control initiatives.

• Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives (e.g., compliance with new registration requirements, or professional development with minimum supervision).

• Mentors regulatory as