Who we are:
Tasso is a fast-growing Seattle-based startup focused on delivering at-home diagnostic testing to those who need it most. We are growing our footprint with leading health systems, clinical research organizations, academic medical centers, and more who are looking to deliver clinical-grade, convenient diagnostic tests to their patients. Tasso was founded to find a better way to collect blood instead of a painful fingerstick or time-consuming venous draw. Since then, our products have been used in pharmaceutical clinical trials, by Olympians as part of a new virtual anti-doping program, and broadly by hospital systems. What you will do:
You will be responsible for coordinating, executing, and/or supporting Class I/II medical device/IVD regulatory submissions to US FDA and international regulatory agencies including EU Notified Body, Health Canada, Australia TGA, Japan PMDA, and other upcoming ROW markets. You will also support quality system and regulatory compliance activities (as required) including supporting Tasso quality system to meet ISO 13485, MDSAP, and EU MDR/IVDR requirements, post-market surveillance activities, vigilance reporting, and internal/external audits in conformance with national and international regulations. This role requires working under tight timelines supporting the Regulatory Affairs team while maintaining communication with QA, Product, Operations, and other functions as required. This position will report to the Director of Regulatory Affairs. Your Duties & Responsibilities: Coordinate and prepare medical device/IVD product submission packages for global regulatory agencies and maintain registrations for Tasso products Liaise with QA, Product, and Operations Respond to RA information requests from global authorities and economic operators Stay abreast of new regulations and guidance in domestic and international regulatory climate Assist with regulatory strategy development and reporting project timelines Assist with the preparation of routine reports and regulatory agency communications Assist with product labeling for compliance with target market labeling regulations Maintain regulatory paper and electronic files Assist with supporting management of regulatory audits (e.g., ISO 13485, Notified Body) Work with QA team on audits, complaints, CAPAs, medical device reporting, and recalls, as required Assist with various administrative and oversight tasks for the RA team What you bring: Bachelor's Degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.)2-4 years of experience working in an US FDA/or ISO 13485 regulated environment and medical device industry Familiarity with US 510(k) and major international market regulations (EU, Canada, Australia, Japan, etc.) for Class I/II medical device/IVD is preferred Familiarity with EU MDR/IVDR is preferred Regulatory Affairs Certification, desirable Proficiency with Microsoft Office Suite, Adobe Acrobat, Electronic Management Systems What We Offer $70-$90K salary + stock options (depending on experience level)100% paid Medical, Dental & Vision for employees and generous subsidy for dependents. Unlimited vacation time + 11 paid holidays 401K + Employer Match Paid maternity/paternity leave Flexible and hybrid work hours We have a strong healthcare-driven mission, and your guidance and efforts will directly link to our success. We embrace diversity and equal opportunity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be for it.
