Senior Regulatory Affairs Specialist

POSITION SUMMARY: 

The regulatory affairs team at Natera is seeking a highly motivated individual to contribute to the success of Natera's women's health and organ health products.  A strong background in in vitro diagnostic devices with experience working with CAP, CLIA and NYSDOH for clinical laboratory tests are highly preferred.  The job involves sustaining our products in the US and worldwide through certifications, registrations, change control management, regulatory strategy and submissions to US and international agencies.  Excellent collaboration skills and cross-functional written and verbal communication of regulatory requirements are sought after and honed in the role.  Consider joining our team at Natera and helping to change the world of medicine. 

PRIMARY 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

QUALIFICATIONS:

• 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.
• Experience with molecular diagnostics and IVDs highly preferred with emphasis on CAP/CLIA/NYSDOH certifications, filings, modifications. 

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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. 
• Ability to organize work, project management experience desirable.