The MDD/MDR Specialist is responsible for ensuring that the company's software which is used as a medical device complies with the Medical Device Regulation (MDR), and ISO 13485 and 14971 standards. This role involves augmenting and maintaining the quality management system, managing regulatory submissions, and ensuring compliance with all relevant regulations. **Key Responsibilities:** · Lead the preparation and submission of regulatory documentation for new and existing medical devices in compliance with MDD, MDR, and ISO 13485. · Maintain and update the quality management system (QMS) to ensure ongoing compliance with MDR, ISO 13485 and ISO 14971 standards. · Conduct gap analyses and implement necessary changes to meet regulatory requirements. · Collaborate with cross-functional teams, including the quality auditor, marketing, and quality leads, to ensure regulatory compliance throughout the product lifecycle. · Monitor and track regulatory changes and provide guidance to the organization on the impact of these changes. · Support the Preparation of and advise on the submission of post-market surveillance reports, adverse event reports, and other regulatory submissions as required. · Support internal and external audits by clients and regulatory bodies. · Provide training and support to staff on regulatory requirements and quality management systems. · Support and review and updated DTAC submissions in the UK and similar standards in other EU countries as applicable. **Qualifications:** · Bachelor's degree in a scientific, engineering, or related discipline · experience in regulatory affairs and quality management systems in the medical device industry Preferred · Strong knowledge of MDD, MDR, and ISO 13485 standards and requirements. · Experience with regulatory submissions to the FDA, EU, and other global regulatory bodies preferred. · Excellent project management, analytical, and organizational skills. · Strong communication and interpersonal skills. Preferred Qualifications: · Experience with CE marking and FDA submissions. · Knowledge of ISO 14971 and FDA QSR Part 820. · Prior experience in a manufacturing or device design authority environment. **Key Competencies:** · Attention to detail and strong problem-solving skills. · Ability to work independently and as part of a team. · Proactive and able to manage multiple projects simultaneously. · Strong sense of ownership and accountability. **Working Conditions:** · Hybrid Office/home based role with occasional travel to regulatory bodies and other IQVIA sites as required. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled