Who we are Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
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
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%
About Us 23andMe, Inc. is the leading personal genetics company. Our mission is to help people access, understand and benefit from the human genome. 23andMe has over 2 million customers worldwide with ~85 percent consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.
At 23andMe we value a diverse, inclusive work force and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
Our mission is to help people access, understand and benefit from the human genome. 23andMe has over 1 million customers worldwide... with over 80 percent consented to participate in research. 23andMe, Inc. is located in Mountain View, CA. More information is available at www.23andMe.com.