Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist plays a key role in supporting the effective implementation of regulatory strategy across Natera’s products and services. This role applies growing technical expertise and a strong understanding of regulatory requirements within at least one regional area of expertise (e.g., US FDA, CAP/CLIA/NYS, EU, Japan, or China) to support the approval, registration, and ongoing compliance of Natera’s offerings.

The Senior Regulatory Affairs Specialist represents the Regulatory Affairs (RA) team to internal and external stakeholders through clear written and verbal communication within at least one product line. This role may represent RA on cross-functional core teams and change control initiatives. Responsibilities include maintaining product registrations, conducting regulatory change assessments, supporting post-market surveillance activities, and managing records of communication with regulatory authorities.

In addition, this role supports the overall effectiveness of the Regulatory Affairs function by contributing to staff development, process improvements, and ongoing awareness of current and emerging regulatory requirements.

RESPONSIBILITIES:

• Support preparation of pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements; Work closely with RA leadership to prepare analytical and clinical pre-submissions that advance project goals.

• Support regulatory submissions for in vitro diagnostic devices including IDEs, EU/IVD Technical Documentation, classification requests, pre-submissions, and updates to registrations worldwide.

• Contribute to the setting of individual and departmental annual goals aligned with business objectives

• Review and ensure regulatory compliance of advertising, promotion and labeling across a common product line

• Support regulatory affairs efforts in new and existing technology project teams to implement regulatory strategy and meet regulatory requirements towards overall success of the project deliverables. Support regulatory initiatives within regulatory affairs.

• Represent Regulatory Affairs in written communication with regulatory authorities

• Contribute to regulatory plans and regulatory change assessments that meet CAP/CLIA/NYS, US IVD, EU IVDR and international requirements.

• Collaborate within the RA team to implement least-burdensome approaches and facilitate time-to-market for Natera products and services.

• Understand and implement regulatory strategy based on existing guidance documents within a particular area of IVDs either CLIA/CAP/NYS, US FDA or EU IVDR. Provide summaries and educational awareness within project sub-teams or in support of project planning.

• Support regulatory deliverables on behalf of internal and external program teams.

• Build specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera; maintain excellent records of regulatory interactions and reports, contribute to the effectiveness of the RA team

• Support RA leadership in implementation of data-driven improvements in RA processes, acquisition of cross-functional leadership skills and core competencies in regulatory affairs.

• Other duties as assigned

QUALIFICATIONS:

• 4-6 years biotech industry experience

• Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education.