[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
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