Employer: 23andMe
23andMe is seeking a Regulatory Affairs Coordinator to support project and group activities/tasks. Reporting to the Regulatory Affairs Manager or Director, in this role you will provide administrative support to the Regulatory Affairs team that focuses on the delivery of new or existing products while conforming to applicable regulations and standards.
Position is currently remote, hours are Pacific Standard Time (PST).
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:
- Prepare project schedules in collaboration with cross-functional core team members
- Track and communicate project status to all stakeholders by preparing status reports/meeting minutes
- Maintain Regulatory Affairs documentation, input data and control access as needed
- Analyze and QC data (training will be provided)
- Compile, package and ship regulatory submissions
- Gather, document and maintain regulatory “intelligence information” for pre-market and post market requirements in US and international countries
- File, organize and retrieve documentation from regulatory archives
- Coordinate/schedule department activities such as requisitions, supply ordering and meetings
- Expense tracking, purchase orders (POs)
- Raise project issues as appropriate
- Provide general group support, as required
What You’ll Bring:
- Science and/or mathematics – genetics, chemistry, biology, statistics, preferred.
- >2 years of administration or project management work experience
- Familiarity of IVD/Medical Device regulations and standards (for example 21 CFR 820, ISO 13485, ISO 62304, ISO 14971), preferred
- General knowledge of project management practices, tools, and methodology
- Expert level use of Word, Excel, Smartsheet/Microsoft Project, PowerPoint, Zoom and Slack
- Experience with document management systems and document sharing systems
- Tenacious attention to consistency and detail
- Excellent communication, presentation and interpersonal skills working with cross-functional teams
- Ability to prioritize and multi-task while maintaining a positive and collaborative attitude
- Flexibility to support changing assignments and priorities in an independent and reliable manner
About Us
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has over 5 million customers worldwide, with ~85 percent of customers consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.