[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 https://www.welldoc.com.

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