What will you be empowered to do?
Senior Specialist, Regulatory Affairs
Sunnyvale, California, United States
You are a highly skilled international regulatory affairs professional with expertise in supporting the day-to-day activities of a dynamic regulatory affairs department. You are a clear and articulate communicator and a great listener and observer that can work effectively with other teams across the organization. In this role, you will combine international regulatory expertise and knowledge of scientific issues to partner with and coach internal stakeholders by providing regulatory guidance needed for international pre and post market compliance. You will ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
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
- Represent regulatory affairs on various cross-functional product development teams to provide input, guidance, and support including regulatory, design verification, and validation strategies to support all the regulatory aspects of the product development lifecycle
- Assess regulatory impact on new projects and/or product changes for regulatory classification for international strategy/registrations
- Contribute to the development and implementation of the Regulatory Affairs groups policies and procedures
- Use knowledge of strategic regulatory concepts and company objectives to negotiate solutions with stakeholders to resolve complex issues in creative and effective ways (solution driven)
- Interface with cross functional departments to ensure proper coordination of regulatory strategy and timelines necessary to meet regulatory requirements
- Monitor international customer experience
- Assess reportability of complaints, and ensure events are processed in accordance with regulatory requirements
- Interface with Customer Care and Quality Assurance to obtain information required for international reportable events
- Escalate reportability issues to management to ensure events are processed in accordance with regulatory requirements
- Prepare and/or review technical documentation related to clinical performance, analytical performance and labeling
- Write and/or 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
What You’ll Bring
- Minimum of a Bachelor's degree preferably in life sciences; an advanced degree is strongly preferred (i.e. MS, MD, PhD). RAPS certification is a plus.
- Minimum of 4-7 years previous experience working in Regulatory Affairs relevant to IVD products; OTC/DTC experience is a strong plus
- Experience developing international submission content such as for STED Technical Files or other global regulatory submissions
- Experience with working and registering with international regulatory agencies.
- Ability to read, analyze, and interpret technical documents, professional journals, technical procedures and government regulations
- Ability to analyze large data sets to further write clear, understandable technical regulatory documents
- Expert use of Microsoft Word, Excel (including formulas and macros), PowerPoint, and experience with document management systems and document sharing systems
- Solid understanding of design control requirements
- Problem solving skills and the ability to get to yes or no quickly
- Initiative, motivation, good judgement, ability to manage multiple tasks
- Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style
- Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders
- Flexibility to support changing assignments and priorities in an independent and reliable manner
23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce 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. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at firstname.lastname@example.org. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.Back