SSI Diagnostica Group · 3 weeks ago
Diagnostic Implementation Specialist
Blacksburg, VA
Full-time
Hybrid
Mid Level
3+ years expSSI Diagnostica Group is a clinical diagnostic company focused on infectious disease diagnostics. The Diagnostic Implementation Specialist will provide technical expertise and support for customers adopting the company's scientific solutions, ensuring successful product deployment and customer satisfaction.
Medical Device
Responsibilities
Provide technical, regulatory, and analytical expertise in customer setup and evaluation
Analyze technical issues by synthesizing multiple sources of potentially conflicting information to understand and assess problems
Conduct research and analysis, applying technical experience and knowledge along with established assessment frameworks and approaches
Assist in developing and implementing methodologies and best practices related to diagnostic testing
Create and deliver training modules and technical documents for customers, technical staff, and sales teams
Collaborate to produce technical marketing materials, including emailers, white papers, and proof sources
Locate, synthesize, and communicate scientific papers, studies, and data effectively
Maintain an updated list of publications featuring TECHLAB products
Create and manage assay onboarding proposals, ensuring compliance with current federal and international regulatory requirements (e.g., FDA, CLIA, IVDR, etc.)
Monitor, interpret, and communicate relevant changes in post-market regulatory guidelines that may affect existing TECHLAB products and customer usage
Collaborate closely with the Technical Services team to support troubleshooting investigations into products
Escalate technical or compliance-related issues to the appropriate departments or regulatory entities, ensuring timely resolution and proper documentation
Partner with Marketing and Sales teams to develop scientific and regulatory-based materials, including white papers, product sheets, slide decks, and FAQs
Translate technical and regulatory insights into user-friendly materials that enhance product value propositions
Offer subject matter expertise during the phases of assay development, validation, and launch
Ensure new products meet applicable regulatory standards and are effectively positioned in the market
Conduct ongoing analysis of the competitive landscape to identify emerging trends, regulatory shifts, and unmet market needs
Required to travel up to 60%
Qualification
Required
Bachelor's degree
Clinical laboratory experience, MLS, or 3-5 years relevant experience required
Excellent communication, strategic thinking skills, and cross-functional collaboration skills
Strong understanding of federal and international regulatory frameworks
Preferred
Experience with open-platform liquid handling instruments (Dynex, Innova)
Experience with Microsoft Office Suite
Experience with Salesforce.com
Company
SSI Diagnostica Group
SSI Diagnostica Group is a global leader in infectious disease diagnostics, bringing together three companies - SSI Diagnostica, Techlab, and CTK Biotech – to support better treatment outcomes for patients worldwide.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase