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Legal and Regulatory Affairs
Principal Specialist - Regulatory Affairs (IVD)
Sunnyvale, California, United States
Who you are
You are a highly skilled regulatory affairs professional, 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 regulatory, scientific and IVD expertise to partner with internal stakeholders by providing regulatory guidance needed for 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
- Prepare technical documentation necessary for regulatory submissions
- Analyze large data sets and assess for compliance with applicable requirements
- Write and/or edit complex and lengthy technical documents for clarity, grammar, spelling, punctuation and consistency
- Develop and maintain other technical documentation required for compliance such as policies, SOPs, regulatory content for design history files
- Interface with cross functional departments to ensure proper coordination of regulatory strategy and timelines necessary to meet regulatory requirements
- Participate in proactive and continuous improvements for Regulatory Affairs and in support of the quality system
- Assess new projects or product changes for regulatory classification (including Class 3, Class 2, Class 1, enforcement discretion, or non-medical device)
- Represent Regulatory Affairs on various cross-functional business or product development teams to provide regulatory input, guidance, and support including design verification and validation strategies to support all the regulatory aspects of the product development lifecycle
- 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)
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)
- Minimum of 7-10 years previous experience working in Regulatory Affairs relevant to IVD products; OTC/DTC experience is a strong plus
- 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
- Travel 0 - 10%
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 Sunnyvale, CA. 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.