N
Us Remote, Canada· Remote
$157K – $218K/yr
PythonSQLExcelPower Bi
N
Role overview
Job description
POSITION SUMMARY: The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES: Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams. Develops strategies for submissions to FDA and other regulatory agencies. Provides risk assessments and regulatory options. Prepares U.S. regulatory submissions n
…About this listing
- Listed from Natera's careers site via Greenhouse · last confirmed on the source 23 Oct 2026
- Posted 30 Sept 2026
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What they are looking for
Skills & requirements
Qualification
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. 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. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $83,000 — $103,700 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing
Department · Regulatory Affairs
Hiring company
Natera
Healthcare
Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.
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