Senior Regulatory Affairs Specialist

Summary

Join Natera's regulatory affairs team as a highly motivated individual contributing to the success of women's and organ health products. You will sustain products through certifications, registrations, and change control management, working with US and international agencies. The role requires strong collaboration and communication skills. Responsibilities include contributing to regulatory plans, preparing submissions, ensuring compliance, and collaborating with teams. A background in in vitro diagnostic devices and experience with CAP, CLIA, and NYSDOH is highly preferred. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families.

Requirements

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred
• Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs or equivalent
• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards
• Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization

Responsibilities

• Contribute to regulatory plans and regulatory change assessments that meet CAP/CLIA/NYS, US IVD, EU IVDR and international requirements
• Prepare pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements; Work closely with RA leadership to prepare analytical and clinical presubmissions 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
• 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 subteams 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

Preferred Qualifications

• Experience with molecular diagnostics and IVDs highly preferred with emphasis on CAP/CLIA/NYSDOH certifications, filings, modifications
• Ability to organize work, project management experience desirable

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program