Senior Specialist, DTx Quality Engineer (Contract)

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. 

About the Role:

The Senior Specialist, DTx (Digital Therapeutics) Quality Engineer is a contract position that has a key role in the development of Click’s Software as a Medical Device (SaMD) products. This position works alongside the Product Management, Software Engineering, and Testing teams and drives the day-to-day product quality activities while implementing Quality Management System (QMS) procedures in alignment with evolving FDA and international medical device regulations. The Senior Specialist, DTx Quality Engineer reports to the Senior Manager of DTx Quality Engineering and has a direct role in bringing Click medical device software to the market.

Responsibilities:

• Work cross-functionally throughout the organization to implement and champion software development lifecycle (SDLC), cybersecurity, and risk management processes for multiple ex-US SaMD products in various stages of development.
• Establish Quality System processes and procedures that comply with applicable regulations, standards and guidance for the design, development, and manufacture of SaMD in ex-US jurisdictions (e.g., United Kingdom, European Union member states, Japan). 
• Develop product-specific expertise to prepare high-quality design control deliverables and records for ex-US SaMD products (e.g., SaMD product requirements and specifications, infrastructure qualification, software architecture, data flows, traceability tables, anomaly logs, risk management files). 
• Coordinate and collaborate with the designated ex-US quality and regulatory roles (e.g., Person Responsible for Regulatory Compliance (PRRC), EU Authorized Representative, Importer) to ensure submissions, product registration, labeling, and post-market surveillance activities are conducted in accordance with relevant regulations.
• Oversee and manage the submission of required documentation and information to regulatory agencies, notified bodies, and applicable registrar databases (e.g., the European Union Database on Medical Devices (EUDAMED)).
• Identify and coach team members on industry best-practices and key-learnings between ex-US SaMD products for the consistent and optimal implementation of the quality system across the organization.
• Lead Quality System efforts with Click’s collaborative partners to effectively execute design and development activities between multiple manufactures according to relevant Quality Agreements.
• Promote a culture of quality and advocate for the importance of product quality throughout the organization.

Qualifications:

• Bachelor’s Degree in engineering or other STEM related field, advanced degree preferred. 
• 5+ years of experience working in a medical device quality system.
• Advanced knowledge of medical device international regulation and standards including UK Medical Device Regulation, EU Medical Device Regulation (EU MDR), Pharmaceutical and Medical Device Act (PMDA), and ISO 13485, additional understanding of international regulations preferred such as ISO 27001, IEC 81001-5-1, MDSAP, EU Artificial Intell