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Senior Regulatory Affairs Specialist

Tasso

Tasso

Legal, Sales & Business Development
Seattle, WA, USA
Posted on Monday, July 17, 2023
SummaryTasso is a fast-growing startup that has developed a painless device to collect blood from people at home for at-home diagnostic testing. Tasso has strong partnerships with pharmaceutical companies, diagnostic testing labs, and healthcare systems that are looking to provide remote ways to access blood data. Tasso was originally founded to find a better way to collect blood instead of a painful fingerstick or time-consuming venous draw and we were originally funded by the NIH and DARPA. 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 across the US.This position is responsible for supporting a variety of regulatory activities and projects under the direction of the Director of Quality & Regulatory Affairs. The primary focus is on the preparation and clearance/approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and EU markets. The position will represent Regulatory Affairs in new product development core team(s), create and execute regulatory strategy, change assessment, complete high-quality regulatory submissions per project plans, maintain regulatory files, and facilitate regulatory post market surveillance and reporting. Essential Duties & Responsibilities
  • Writes and leads the completion of high-quality 510(k)s and EU Technical Documentation (MDD/MDR/IVDD/IVDR) with limited supervision
  • Obtains FDA clearance of 510(k)s and Notified Body’s approval of Technical Documentation with desired claims per project plan
  • Represents RA in new product development team(s). Responsible for completion of regulatory strategy, review, and approval of design control related documents.
  • For changes to products and processes, conducts regulatory assessments, authors, and maintains Letters to File and technical files updates
  • Maintain knowledge of industry trends in products and services, regulatory environment, noncompliance trends, and emerging industry best practice by continually reviewing relevant resources for new information
  • Solve problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion
  • Support QA team to ready and host third-party audits. Consult and support in related planning and response.
  • Assists in implementing department procedures and maintaining regulatory requirements
  • Provides support to the Director of Quality & Regulatory Affairs, and performs other related duties and assignments, as required
  • Provides guidance and mentorship to junior staff
Qualifications/Experience
  • Bachelor of Science Degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.)
  • 5+ years of experience working in US and EU regulatory affairs in the diagnostic medical device industry, or other related experience
  • 3+ years of US 510(k) and EU Technical Documentation experience for Class II medical device/IVD products
  • US IVD experience is required
  • EU MDR/IVDR experience is preferred
  • Knowledge of CLIA laboratories is preferred
  • Regulatory Affairs Certification, desirable
Job Requirements:
  • Excellent project management, negotiation, communication (written and verbal), and interpersonal skills
  • Ability to communicate and work in a diverse team environment
  • Effective interactions with technical personnel (Product, R&D, Clinical)
  • Excellent team skills with ability to influence others without authority
  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
  • Ability to identify areas of concern in moderately complex projects and manage changes
  • Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency, and driving for results
  • Ability to write high-quality submission documentation
  • Proficiency with Microsoft Office Suite, Adobe Acrobat, Electronic Management Systems
  • Detail oriented with emphasis on accuracy and completeness
Compensation Package$90,000 - 120,000/yr base + Stock Options
  • We offer competitive compensation, benefits and a fantastic work environment:
  • 100% paid Medical, Dental & Vision for employees and generous subsidy for dependents
  • Unlimited PTO policy
  • 401K + Employer Match
  • Flexible work from anywhere (remote) environment
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.Powered by JazzHRFeHeT0qEPP