[Remote] Regulatory Affairs Intern

Note: The job is a remote job and is open to candidates in USA. Welldoc is at the forefront of digital health, driven by a mission to empower better cardiometabolic health through AI-powered technology. The Regulatory Affairs Intern will support the compliance of products with global regulatory requirements, enabling safe and timely market access while working remotely. Responsibilities Support the monitoring of new and updated medical device regulations and standards Support the maintenance of regulatory documentation, including EU technical files and post market surveillance reports Partner with internal teams to gather necessary data and documentation for regulatory submissions and document updates Participate in cross-functional meetings to provide regulatory input on product development and design changes Support the generation of Unique Device Identification (UDI) to ensure labeling requirements are met Contribute to the development and revision of regulatory related Standard Operating Procedures (SOPs), work instructions and processes Identify and collaborate with key stakeholders such as Product Development, Clinical, Quality Perform other assigned duties to support the regulatory department Skills Basic understanding of medical device regulations in key markets such as US (FDA 21 CFR), EU (MDR), Canada (Health Canada), Japan (PMDA), and Australia (TGA) Strong analytical, conceptual, and problem-solving abilities Excellent attention to detail and organizational skills Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and Google Docs Strong written and verbal communication skills Excellent project management, interpersonal, teamwork, and time management skills Driven team member with multitasking and prioritization skills Agile, responsive, and eager to learn General knowledge of industry standards, including ISO 13485, ISO 14971, IEC 62304, and IEC 62366 Currently pursuing a bachelor's degree in a relevant field such as Regulatory Affairs, Engineering, Life Sciences, or related field Company Overview Welldoc is a digital health platform that helps in managing chronic conditions. It was founded in 2005, and is headquartered in Columbia, Maryland, USA, with a workforce of 51-200 employees. Its website is