MEDTECH BUSINESS ANALYST - CONNECTED REGULATORY INTELLIGENCE

MedTech Business Analyst - Connected Regulatory Intelligence The IQVIA Connected Regulatory Intelligence (CRI) is a groundbreaking innovative solution that simplifies, integrates, and automates end-to-end regulatory processes that are essential for industry clients in meeting their global quality, regulatory and safety compliance obligations.
The CRI solution leverages IQVIA's unique regulatory intelligence platform to allow users to seamlessly query IQVIA's intelligence as well as their own organization's insights and Health Authority Interactions (HAI) to improve and accelerate quality, regulatory and safety activities such as strategic planning, submission management and publishing work amongst others.
Position Purpose This role is a member of the CRI product team and will be responsible for the analysis of the MedTech regulatory affairs business processes and systems The individual will engage with industry experts and global intelligence sources that cover a wide range of Medical Device types and geographic locations to write business requirements and will translate those into documentation that can be used by the software development teams The role will work with teams that own several regulatory software applications that leverage the Connected Regulatory Intelligence Platform and support with the development of optimized solutions and workflows that leverage the CRI product The individual fulfilling this role will also help the definition of additional intelligence required in the platform to further drive regulatory process automation This role will involve actively interacting with customers and industry experts to discuss regulatory processes, user experience and software implementation to gather and document customer feedback Principle Accountabilities.
To Accomplish this role, the candidate will apply their experience of MedTech regulatory activities and the knowledge of current regulations and standards across the globe to.
Define the regulatory business requirements for the software applications Translate the business requirements into technical documentation Create high-level solution concept diagrams that detail how to solve the problem Facilitate brainstorming, visual collaboration and diagramming sessions between all the stakeholders, business experts and engineering teams Successfully complete technical documentation and support the development and QC activities across the development lifecycle Continuously monitor and update new, revised, or emerging global regulatory requirements as required by the business in order to maintain the curated data in the CRI product and the associated interfaces with other IQVIA solutions Experience and Skills Required.
Qualifications in engineering, life sciences or related discipline In-depth understanding of global and country specific regulatory requirements Developing regulatory strategy for Design, Development, V&V, Manufacturing, and Production Controls for global releases Change Management and New product registrations Preferably experience in a range of medical device product types and risk classes Possesses at least 5 years of relevant regulatory affairs experience and\/or technical expertise preferably in preparing application dossiers and agency interactions Experience in quality management requirements (e.
., 21 CFR and\/ or ISO implementations) Knowledge and experience using software systems developed for regulatory, safety, clinical and quality (validated systems) will be an advantage Ability to become the liaison between the business and the technical development teams Demonstrated ability to manage and drive project contributions in a timely manner Ability to create strong working relationships across the organization.
collaborating with cross-functional teams including technology, regulatory, quality, clinical affairs, and others Self-motivated and enthusiastic Strong analytical and problem-solving skills The opportunity.
You will be working on a groundbreaking innovative solution and directly impacting patient health through transforming client operations that bring safe and effective medical product to global markets in optimized timelines.
We are a diverse, global team that shares a passion for collaboration and solving problems using best functional expertise and most advanced technologies to transform how regulatory teams do their daily jobs.
Together, we will make a difference.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
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