Planning, coordination, and preparation of document packages for regulatory submission across different projects:• Authoring and coordination of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow-up (PMCF) checklists, plans, and activities. Development, maintenance, and adherence to the scheduling and management of PMS & PMCF plans and reports, and clinical evaluations.• Preparation of relevant information/responses for regulatory submissions and EUDAMED working with co-workers of the QA/RA department.• Provide input to Post Market Surveillance (PMS), Risk Assessment, and CER interdependency strategies.• Participation in internal and external regulatory audits as required and liaise with other functional units (Engineering, Clinical, Marketing, Technical writing, Quality, etc.) regarding the relevant requirements for PMS, CER, and PMCF and ensure the outputs from the individual functional units meet the applicable regulatory requirements.Collaborating with strategists, architects and project managers, developers, and testers during the development phase, playing a pivotal role in all phases of SDLC by using product and domain knowledge to clarify product requirements & user stories for the development team, and responsible for analyzing business requirements.• Responsible for coordinating and implementing new clinical-related product features and collaborating with UX designers and the engineering team to design and build products.

• Define and document vision, functional requirements, and risk analysis using solution management tools and processes.• Translate user stories and requirements from epics, features, solution visions, and market needs into clear product and risk control requirements.• Collaborate with clients to develop applications and ensure functional requirements are met and approve the solution for release.• Support Cerner sales processes, including demo support, RFP questions, and training sales associates.• Groomed the backlog and broke down product requirements for development of PharmNet Inpatient Application by one or more scrum teams.• Clarified product requirements and user stories for the development team using product and domain knowledge.

• Create a product scope document for clinical modules• Manage the requirements pipeline for assigned product(s), aligned with commercial and product strategy• Communicate with clients/sales teams to comprehend their expectations and market demands.

• Gathering Requirements from clients. • Organize client requirements by module• Create Functional Specification Documents to translate business needs into understandable language for Dev Team• Coordinate with UI designers during GUI design for clients• Conduct KT Sessions for Dev, QA, and Documentation Teams• Review Test Cases written by QA Team• Conduct functional testing of application and report bugs• Handle change requests from clients• Trace requirements during Implementation• Assist in Managing Project Scope• Train trainers for super-users and module champions.

Roles:• Understand project requirements and explain to dev team• Write requirements based on Marketing Requirements Document• Develop prototypes to match requirements• Provide functional support during testing, including teaching• Assist QC in creating testing plans• Analyze business and software requirements for healthcare• Communicate with UK and US clientsExpertise:• Clinical Processes, incl. Patient Administration and Laboratory Information Systems• Knowledge of Insurance Providers and Healthcare Plans.