Our Mission is to Map the Universe of Biology.Improving the human condition is what fuels our passion for finding new ways of enabling scientific exploration. As a company, we strive to create end-to-end solutions that are simpler, easier, faster and more relevant to today's life science challenges.As the pioneer in the field ofspatial biology,NanoStringenables scientists across the globe to envision molecular interactions in three dimensions with three different systems, the, the(DSP) and the(SMI) platform. As a result, scientists can see themultiomicexpression of genes and proteins in the natural context of tissue structure.Since our founding in 2003, we have earned a reputation as a respected, trusted pioneer of innovative technologies that support our customers in their relentless pursuit of answers. Our products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under the direction of Dr. Leroy Hood.With our technologies, our customers continue to extend our understanding of biology to answer previously unsolvable questions with consistent, reliable results.However,NanoStringis much more than innovative products. The secret sauce to the company's success is our people, who are committed to excellence and dedicated to catalyzing the next biological revolution. Collectively, we live our corporate values of ambition, grit, ingenuity, authenticity, and customers every day...and never stop asking "What if?"The Senior, Regulatory Affairs Specialist is responsible for maintaining Regulatory Affairs documentation and assisting the department efforts towards achieving and maintaining global compliance for the company's products. Also, acting as the regulatory representative on core teams culminating in the preparation of relevant regulatory filings, tests, and certifications as applicable, with a particular focus on life sciences instrument/software development and manufacturing.Essential Functions:Maintain Regulatory Affairs documents, policies, plans and procedures to support compliance with regulatory complianceReview labeling/promotional/advertising materials, and other documents to ensure regulatory complianceRepresent and/or lead Regulatory affairs in project team meetings throughout the lifecycle of large-scale projectsAssist in the interpretation and submission of domestic and international regulatory registrations, testing and certificationsAssist regulatory initiatives for compliance and risk managementInterpret RA policies and guidance and correctly apply them as regulatory activitiesManage for the successful execution of regulatory plansParticipate in internal and external Quality auditsMaintain current knowledge of relevant regulations and trends, including proposed and final rulesUse excellent time management, verbal and written communicationsPreferred Qualifications:Preferred education/experience includes bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus3-5 years of experience in Regulatory Affairs, or equivalent combination of education and experience in Regulatory tasks.Strong intellectual capacity and curiosity desiredCertifications: RAC, CQA, CQM preferredTarget Base Salary Range:$87K - $120KBase salary is an integral part of NanoString's total compensation package. Base salary considers an individual's skills, experience, and competitive market value. The base salary range represent what NanoString pays for a job within a salary grade based on external market data in comparison to similar positions from other companies in our industry. Employees generally enter a salary grade at the lower-to-mid-point in the range.Other compensation elements include a discretionary annual bonus, incentive compensation for sales roles