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Welldoc · 1 month ago

Regulatory Affairs Intern

United States

Internship

Remote

Intern

$20/hr - $25/hr

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.

Artificial Intelligence (AI)DiabetesHealth CareMobile AppsReal TimeSoftwareTherapeutics

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

Qualification

Medical device regulationsRegulatory documentationMicrosoft Office proficiencyAnalytical skillsProject managementMultitaskingEager to learnISO standards knowledgeTeamworkCommunication skillsAttention to detailTime managementProblem-solvingInterpersonal skills

Required

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