Medullan is at the forefront of Digital Medicine product development, working with our clients to deliver state-of-the-art consulting and technology driven solutions which help provide improved quality of life outcomes for patients worldwide. Medullan is looking to grow its team by adding an experienced RQC Business Analyst.
The RQC Business Analyst is a key participant in ensuring our teams deliver quality solutions that exceed our clients' and their customer's expectations. You'll be part of the Regulatory, Quality and Compliance (RQC) practice, which works closely with Medullan's other practices as well as clients. The RQC practice provides guidance and support for product development, quality management and regulatory & risk-management based consulting services. The Business Analyst will perform research and analysis of information security, legal, privacy and regulatory factors related to primarily Digital Medicine product solutions as well as Digital Health solutions. The Business Analyst will also be responsible for working with the Delivery Teams to create and maintain the Quality Management System (QMS) and integrated tool components used for regulated software (SaMD) products, including Document, Change and Risk Management, Design Controls, and Verification/Validation work processes. Risk management includes vendor/contract management support, both for Medullan (relative to its subcontractors) and for our clients (relative to their various third-party vendors and partners).
Build and apply knowledge and practical application of global Medical Device regulations, standards and guidance, in order to perform as a Subject Matter Expert for Medical Device product development
Work with client and product teams, develop and document appropriate medical device design control processes and artifacts.
Collaborate with cross-functional teams composed of product management, user experience, technology, digital strategy, and other subject matter experts to gather and analyze legal, regulatory and compliance needs and requirements, dependencies, and impacts, across multi-market and regulatory jurisdiction boundaries.
Understand client project and/or product business goals, align and document a product's vision/goal, objectives, success metrics/criteria, value proposition, key users, and user scenarios.
Perform activities related to supplier and vendor management activities, including risk, compliance, and contract management.
Support document management organizational processes, such as contracts and eQMS documents in internal and third-party systems (e.g., familiarity with ContractWorks, Greenlight Guru, and other document management systems).
Desired Skills and Experiences:
Experience in Medical Device, SaMD or SiMD
Experience working in Quality Management System (QMS) environments
Understanding of Regulatory organizations and frameworks such as HIPAA, FDA, GDPR, EU MDR, ISO 13485, 14971, 62304 and 27001
Solid experience in gathering requirements, business rules, and documentation of software applications
Experience working in a client facing, consulting environment
High energy level, with strong verbal/written communication skills
Experience leading workshop style meetings to identify, define and chart a product's functional requirements is a plus
Experience working in Agile/SCRUM environment is a plus