Deciphex

• Territory Development & New Business Growth. • Build and execute a territory plan targeting hospital labs, independent pathology groups, and POLs. • Develop and maintain a qualified pipeline aligned with revenue target. • Prospect actively through direct outreach, industry networking, conferences, and referrals. • Convert qualified opportunities into signed service agreements. • Consultative Selling Position Diagnexia as a scalable subspecialty coverage solution. • Identify client pain points including: Subspecialty coverage gaps (e.g., GI, GU, Derm, Breast), Rising locum tenens costs, Recruiting challenges in difficult geographies, Turnaround time pressures, Burnout and uneven workload distribution. • Demonstrate financial and operational ROI versus traditional staffing models. • Relationship Management. • Develop trusted advisor relationships with Pathologists, Medical Directors, Laboratory Directors, Hospital administrators. • Support onboarding and long-term account growth. • Sales Execution & Reporting. • Maintain disciplined CRM documentation. • Forecast accurately. • Manage sales cycle timelines. • Collaborate with marketing and operations teams.

• This is a remote role with some travel required to global offices. • Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services. • Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America. • Make submissions for regulatory and accreditation applications for new products/services to project timelines to the applicable regulatory bodies. • Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada. • Support Regulatory Affairs team with UK, EU, Rest of World submissions as needed. • Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities. • Coordinate post market surveillance (PMS) activities for products and services. • Write and submit periodic regulatory reports to authorities as required. • Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with global regulations. • Keep up to date on changing regulatory requirements and standards including FDA/LDT rule changes, emerging AI regulations, privacy/security regulations etc. • Conduct regulatory gap analyses and impact analysis. • Develop internal and global policies & procedures to ensure continuous compliance with all regulatory requirements. • Assist in maintaining the Regulatory Affairs Intranet site. • Collect and report on compliance metrics as directed by the Regulatory Affairs Manager. • Support other members of the Quality team to incorporate regulatory requirements into the Integrated Management System (IMS). • Review of Change Requests for product & service changes which may impact regulatory and customer filings. • Support employees with regulatory queries, customer audits, regulatory audits and inspections as required. • Perform internal & supplier audits as required. • Develop and deliver company training modules on regulatory processes. • Complete all mandatory company training and job specific training required for the role, including Information Security Management System (ISMS), GLP, DocuSign, SDLC as applicable.

• The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager, supporting software quality for medical device product development • Software Quality for product development • Software lifecycle & AI model governance: Software Testing oversight: Own QA oversight of testing activities by reviewing and approving strategies, plans, and reports for software and AI verification and validation, ensuring adequate coverage of safety‑critical and AI‑critical functions • Support validation activities for software and processes: assist in the preparation of IQ/OQ/PQ documentation, test protocols and validation reports for IVD software and regulated tools used in US and Canadian GxP environments • Provide QA oversight across the full software and AI model lifecycle (requirements, design, implementation, V&V, release, maintenance) • Risk management: Lead and maintain end‑to‑end risk management for software and AI (hazard identification, analysis, control, and ongoing review) • Assist with compilation and maintenance of the design history file (DHF) and technical documentation under manager oversight • Support control of nonconforming products: document, track and follow up on nonconformances • Support labelling and instructions for use (IFU) review: check compliance of product labelling and user information with FDA and Health Canada requirements • Quality Management System (ISO 13485 / MDSAP) Maintain and update QMS documents and records • Support preparation and execution of internal audits: compile audit evidence, coordinate schedules, record findings, and track closure of audit actions under the direction of the Manager • Coordinate and track QMS training: maintain training records and competency matrices; schedule and confirm delivery of QMS and role-specific training across the organisation

• Work with a mature cross functional agile teams on a hugely successful flagship product for the business • Develop on-premise components, cloud microservices and and integrate with modern cloud platforms • Design, develop and test architecture changes, product features and improvements • Use containerization and cloud technology (compute, network and storage) to build, deploy and execute services and applications in the cloud • Support product monitoring and troubleshooting to ensure high-quality standards • Drive development team best practices and standards • Participate in peer reviews and promote good quality, secure development practices • Collaborate with other teams to improve existing products, services and tools • Complete all mandatory company-wide compliance training and job-specific training required for the role, including QMS, ISMS, GxP, DocuSign, SDLC as applicable

• As an individual contributor, you'll build your own weekly plan, run your own schedule, and take real satisfaction from turning first conversations into recurring revenue . • You will be instrumental in finding, shaping, and closing strategic pathology partnerships/ sales • You will map your territory, build and prioritize target lists, reach out to potential clients, and turn interest into formal agreements. • You will spend most of your time prospecting remotely, with around 30 - 50% travelling. • You'll sit down face to face with key senior decision makers, strengthen relationships, and seal deals/ exceeding sales targets & quotas • You will focus on hospital laboratories, regional reference labs, and physician office labs, positioning Diagnexia digital pathology services as a cost effective, high quality alternative. • You will read the market, refine your approach based on what you see, and keep a tight, realistic pipeline so effort goes where it will move the needle. • You'll hit and achieve new business sales targets • Training required for the role, may include ISMS, GLP, DocuSign and GDPR awareness.