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. Backed by Lightspeed and Sequoia.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- 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
- Remote USA
- $83,000 — $103,700 USD
More about this role
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.
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 necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements. Prepares and/or compiles information required by ex-U.S. regulatory associates to register or...
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