Sr. Manager, Regulatory Affairs (IVD)
23andMe is looking for a highly skilled, solutions-driven regulatory affairs professional with expertise in managing 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 regulatory expertise and knowledge of scientific issues to partner with and coach 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
- Oversee the FDA regulatory submissions process, including development of strategy, submission structure, gathering submission materials from stakeholders, and direct negotiations with FDA review teams
- Write de novo, 510(k), and medical device pre-submissions
- Contribute to the regulatory review of labeling and promotional documents for accuracy and adherence to FDA/FTC laws, requirements and guidance
- Strategize and collaborate with marketing teams to support development of a variety of different types of consumer media, including but not limited to display advertising, radio ads, email communications, social media, press, affiliate communication, blogs, video content, retail marketing and event materials
- Resolve regulatory inquiries related to marketing, such as media claim substantiation
- 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 other stakeholders to resolve complex issues in creative and effective ways
What you’ll bring
- Minimum of a Bachelor’s degree preferably in life sciences; an advanced degree is strongly preferred (MS, MD, PhD)
- Minimum of 7-10 years previous experience working in Regulatory Affairs relevant to OTC/DTC and IVD products
- 3-5 years experience with direct people management
- Problem solving skills and the ability to get to yes or no quickly
- Initiative, motivation, good judgement, ability to manage multiple tasks
- Ability to write clear, understandable technical regulatory documents
- 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
- 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. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, 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 millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. 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 email@example.com. 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.
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Job posted: 2020-10-16