Diagnostic Implementation Specialist

SSI Diagnostica Group•Blacksburg, VA

3d•Onsite

About The Position

Join our team at the Techlab site, part of the SSI Diagnostica Group, as a Diagnostic Implementation Specialist and help shape the future of healthcare technology. This is an opportunity to contribute to meaningful innovations in a collaborative environment focused on improving patient outcomes. We are a global company specializing in the design, development, and manufacture of IVD medical device kits. Our mission is to improve patient outcomes and transform healthcare delivery through technology and a commitment to quality. Our portfolio includes solutions for infectious disease, respiratory conditions, and blood-borne illnesses. We foster a culture of collaboration, continuous learning, and professional growth.

Requirements

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.
Experience with Microsoft Office Suite.
Experience with Salesforce is required.
Ability to travel up to 60% is required.

Nice To Haves

Experience with open-platform liquid handling instruments (Dynex, Innova) preferred.

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 manage assay onboarding proposals, ensuring compliance with current federal and international regulatory requirements (e.g., FDA, CLIA, IVDR, etc.).
Lead customer onboarding and provide comprehensive product training.
Partner with internal stakeholders to develop scientific and regulatory-based materials, including white papers, product sheets, slide decks, and FAQs.
Locate, synthesize, and communicate scientific papers, studies, and data effectively.
Monitor, interpret, and communicate relevant changes in post-market regulatory guidelines that may affect existing TECHLAB products and customer usage.
Collaborate closely with internal teams 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.
Translate technical and regulatory insights into user-friendly materials that enhance product value propositions.
Conduct ongoing analysis of the competitive landscape to identify emerging trends, regulatory shifts, and unmet market needs.
Required to travel up to 60%.