Regulatory Affairs Specialist - Direct-to-Consumer Genetics - Mountain View, CA | Biospace
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Regulatory Affairs Specialist - Direct-to-Consumer Genetics

23andMe, Inc.

Mountain View, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

What you’ll do
The Regulatory Affairs Specialist is an integral member of the Regulatory Affairs team. In this role, you will provide advanced regulatory expertise to guide cross-functional partners in support of day to day operations and new product development for Traits and Wellness reports, and other Class II exempt products.

Represent Regulatory Affairs on various cross-functional product development teams to provide guidance and support including regulatory, design verification, and validation strategies to support all the regulatory aspects of the product development lifecycle

Interface with cross functional departments to ensure proper coordination of regulatory strategy and timelines necessary to meet regulatory requirements

Assess regulatory impact of product changes on US and/or International regulatory strategy

Develop, and maintain technical documentation required for compliance such as policies, SOPs, regulatory content for design history files

Prepare and/or review technical documentation related to clinical performance, analytical performance and labeling

Edit complex and lengthy technical documents for clarity, grammar, spelling, punctuation and consistency
Participate in proactive and continuous improvements for Regulatory Affairs and in support of the quality system

Manage regulatory documentation (e.g., technical files, device listings, UDI, permits, certificates licenses, CLIA Categorization)


What you’ll bring
Minimum of a Bachelor's degree in a life science is required (genetics or molecular biology preferred). Advanced degree (e.g. MS, PhD, JD) is preferred.

Experience in the design and conduct of analytical studies;  experience with genetic studies strongly preferred.  A strong client customer service orientation is required.

> 5 years of experience in pre and post market regulatory affairs that includes IVD’s

Current working knowledge of FDA QSR 21 CFR 820, U.S. medical device and in vitro diagnostic regulatory requirements, IVDD/IVDR requirements, and ISO standards (e.g. 13485, 14971, 62304)

Expert level understanding of design control requirements

Problem solving skills and the ability to appropriately evaluate a situation and prioritize factors for decision making

Must be able to write clear, understandable technical regulatory documents

Ability to compile data and summarize results

Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations

Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style

Ability to prioritize and multi-task while maintaining a positive and collaborative attitude

Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders

Flexibility to support changing assignments and priorities in an independent and reliable manner

Travel 0 - 10%