Regulatory Affairs Manager
Seattle, WA, USA
Posted on Wednesday, August 16, 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.We are seeking an experienced Regulatory Affairs Manager to lead the execution of Tasso’s regulatory strategy within the dynamic medical device industry. This pivotal role involves close collaboration with the entire organization to implement a robust regulatory strategy aligned with the company’s overarching business objectives. As the primary point of contact for regulatory inquiries, the Regulatory Affairs Manager will provide invaluable guidance to the team and ensure our regulatory efforts align with the latest industry standards. The ideal candidate will possess a deep understanding of the regulatory requirements of the FDA, CE, and CLIA for IVDs & medical devices, software, and laboratory diagnostics. This position will report to the Director of Quality & Regulatory Affairs. Essential Duties & Responsibilities
- Collaborate closely with the Director of Quality & Regulatory Affairs to align regulatory strategies with quality management goals.
- Represent Regulatory Affairs on cross-functional teams, collaborating with Operations, R&D, QA, Product, and other departments as needed, and report progress and updates to the Director.
- Develop and execute global regulatory strategies for IVD/medical device products, encompassing submissions, registrations, and ongoing maintenance, in coordination with the Director's strategic direction.
- Lead and manage the preparation of high-quality regulatory submissions, including 510(k)s, EU Technical Documentation (MDD/MDR/IVDD/IVDR), and international submissions (e.g., Health Canada Class II), in accordance with the Director's guidance.
- Facilitate interactions with regulatory bodies (FDA, NB, etc.), addressing informational requests and participating in audits, and provide input to the Director on regulatory interactions.
- Employ sound science-based decision-making to address complex regulatory challenges and devise effective strategies, collaborating with the Director to ensure alignment with quality objectives.
- Interface with external regulatory experts, integrating feedback to refine and execute the regulatory strategy, and provide insights to the Director.
- Participate in risk management activities and ensure their integration into regulatory strategies, collaborating with the Director to ensure a holistic approach.
- Oversee regulatory compliance, charting the roadmap for interactions with FDA, EU, and other regulatory entities, and coordinate with the Director for strategic direction.
- Lead a team in executing the regulatory strategy, including coordination of FDA submissions and correspondence, reporting progress to the Director.
- Monitor and stay updated on changes to regulations, standards, and guidance documents, proactively advising management on business implications, and working with the Director to strategize adaptations.
- Foster awareness of customer requirements and communicate the significance of meeting customer, statutory, and regulatory needs, in alignment with the Director's quality goals.
- Handle additional duties as assigned by Management to contribute to Tasso's business objectives, working closely with the Director to ensure cohesive efforts.
- Bachelor of Science Degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.)
- 8+ years of experience working in US and EU regulatory affairs in the diagnostic medical device industry, or other related experience
- 5+ years of US 510(k) and EU Technical Documentation experience for Class II medical device/IVD products
- US IVD experience is preferred
- EU MDR/IVDR experience is desirable
- Knowledge of CLIA laboratories is desirable
- Regulatory Affairs Certification, desirable
- Excellent time management, verbal and written communication skills
- Management and performance management experience
- Must be able to work independently, manage tight timelines and changing priorities
- Medical Device industry experience
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software
- Extremely detail-oriented with strong organizational skills and high-quality standards
- Electronic Management Systems, desirable
- 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
- Hybrid work policy on-site in Seattle, WA