Who We Are:
NanoString Technologies (NASDAQ: NSTG) is a leading provider of life science tools for discovery and translational research. The company’s nCounter® Analysis System is used in life sciences research and has been cited in more than 3,800 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications. The company’s GeoMx® Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections. Built on pioneering principles in 2003, NanoString is blazing new trails and exploring new frontiers to adapt to the everchanging landscape and becoming smarter and more innovative in the process. We are dedicated to advancing scientific discovery and providing solutions that can have a meaningful impact in research and discovery.
Our purpose is to Map the Universe of Biology. We enable scientists to answer questions they have always wanted to ask to explore the boundaries of cellular structures and create an atlas of biological interactions that define life. We are relentless in our quest to Catalyze the Next Biological Revolution leading to Advancing the Human Condition. In addition to a pioneering spirit, we value: Grit. Authenticity. Ambition. Ingenuity. Customers. Join our team!
The Manager, Regulatory Affairs is responsible for acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to FDA, with a particular focus on companion diagnostics.
- Participate on product design teams
- Create, evaluate, and update Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Review labeling/promotional/advertising materials, and other documents to ensure compliance
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Interpret RA policies and guidance and correctly apply them as regulatory activities
- Develop, manage, and execute regulatory plans for large-scale projects, including companion diagnostics
- Manage direct reports for the successful execution of regulatory plans
- BA/BS degree is required
- 6+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
- Previous in vitro diagnostic (IVD) industry experience
- Previous experience with 510(k)
- Working knowledge of FDA QSR and ISO 13485 regulations
- Excellent interpersonal skills with the ability to influence others in a positive and effective manner
- Strong organizational skills and the ability to support multiple projects
- Demonstrated ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
- Proven ability to work on product development teams
- Intellectual curiosity and an ability to digest complex technical data
- Preferred education/experience includes bioengineering, biological, physical, clinical and regulatory sciences.
- Advanced degrees (MS, MBA, PhD., etc.) a plus
- Strong instrument and software development experience
- Molecular assay and multiplex instrument regulatory experience
- Regulatory experience with global submissions
- Certifications: RAC, CQA, CQM preferred
NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.
COVID-19 VACCINATION REQUIREMENT: NanoString has a COVID-19 vaccination policy that applies to ALL U.S. employees (regardless of work location), onsite contractors and visitors except as prohibited by applicable law. As a condition of employment, newly hired employees are required to provide proof of full vaccination within 31 days of their hiring date or have applied for an exemption for which an accommodation can be made. Being fully vaccinated means that an individual is at least two weeks past their final (or only) dose of an authorized COVID-19 vaccine regimen. Exemptions will be considered for medical conditions/disabilities and sincerely held religious beliefs, observations, or practices. For any visitor coming onsite to one of NanoString’s facilities, we must verify that the visitor is fully vaccinated against COVID-19 prior to site entry and visitors must don a face mask at all times when onsite in a NanoString facility.
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