IQVIA Regulatory Intelligence provides instant access to regulatory insights and real-time updates from national authorities across the globe, helping you to avoid the resource-intensive process of gathering, organizing, and sharing important regulatory information. IQVIA Regulatory Intelligence services cover more than 110 countries, regions, and international organizations. IQVIA RI supports pharmaceutical and medical device companies by providing access to up-to-date and comprehensive original and translated regulatory documents, expert country summaries, tabulated comparative regulatory information covering operational details and timely alerts with state-of-the-art functionality. 

OVERVIEW OF ROLE 

Based in our India office (Bangalore / Gurgaon), We seek a skilled Individual contributor proficient in applying subject matter expertise. The successful candidate will be responsible for the creation and upkeep of high-quality regulatory intelligence content focusing on Medical Devices Content. Responsibilities also include managing day-to-day operations for IQVIA Regulatory Intelligence, covering planning, client delivery, and maintaining quality standards.

RESPONSIBILITIES 

•    Prepare, review, and update regulatory documentation for medical devices, ensuring alignment with guidelines issued by regulatory authorities.
•    Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence related to Medical Devices content, adhering to defined QMS processes.
•    Perform quality control checks on contributions from external experts related to medical device content. 
•    Provide expertise on medical devices to address inquiries from customers, sales, marketing, and business development teams.
•    Acts as a Subject Matter Expert (SME) in regulatory knowledge for medical devices, with a comprehensive understanding of medical device vigilance processes, including adverse event reporting, risk assessment, and regulatory compliance with country-specific requirements.
•    Possess in-depth knowledge of medical device QMS, clinical studies, and submission processes for US FDA, MDR, Singapore and Canada requirements.
•    Manage workload effectively by understanding the scope of work and deliverables, ensuring timely and accurate outcomes.
•    May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
•    May conduct and present regulatory training sessions for small groups or individuals within the RI team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

•    Proven experience and tenure working in Medical Devices within Life Sciences (within regulatory authority, consultancy, or industry) in the US/APAC region and other key global markets.
•    A degree in life sciences and supplementary education with a Medical Devices component would be an advantage.
•    Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
•    At least 5-8 years of relevant experience
•    Ability to communicate clearly and effectively (verbally and in writing) and experience in writing summaries/reports for different audiences.
•    Strong attention to detail, proactive, and highly organized
•    Knowledge of quality management within Life Sciences
•    Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
•    Strong software and computer skills, including Microsoft Office, publishing applications, and tools, as applicable.
•    Demonstrates self-motivation and enthusiasm.
•    Ability to work on several projects, with direction from senior staff as appropriate.
•    Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
•    Ability to adapt quickly to a rapidly changing environment.  

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