Regulatory Affairs Intern

Company & Culture

Welldoc is at the forefront of digital health, driven by a powerful mission: empowering better cardiometabolic health through AI-powered, personalized digital tech, with a vision to be the leading advanced AI digital technology partner across the healthcare industry. We're a team passionate about leveraging cutting-edge science to improve lives, united by core values of collaborative innovation, accountability to excellence, customer focus, efficiency, and unwavering integrity, quality, and safety.

At Welldoc, you'll thrive in a collaborative and innovative environment where your contributions directly impact our mission. Recognized as a Great Place to Work for the past four years and named to Modern Healthcare's Best Places to Work 2025, as well as being an industry thought leader featured at SXSW and in the Wall Street Journal and Economist, we invite you to make a real difference in healthcare with us.

Job Purpose

To support Welldoc by ensuring products comply with global regulatory requirements, thereby enabling safe and timely market access. This internship is available immediately for approximately 15-20 hours/week and will last between four and six months depending on projects and schedules.  The ideal candidate will work remotely but reside in either the San Diego, CA or Columbia, MD area in order to periodically meet in person with team members.

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.

Required Skills & Experience

• 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.

Welldoc operates in ISO 13485 and MDSAP regulated and HITRUST and SOC 2 Type II compliant environments.  Therefore, it is expected that all employees will have either prior experience working in those environments or will be trained to understand the requirements needed to work and support those requirements and culture as they relate to individual roles and responsibilities.

Required Education

• Currently pursuing a bachelor's degree in a relevant field such as Regulatory Affairs, Engineering, Life Sciences, or related field.

Compensation & Benefits

The anticipated salary range for this position is between $20-25/hour with the expectation that most candidates will fall around the midpoint of the range. Exceptional candidates may exceed the range if education and experience warrant.

Upon receipt of a conditional offer of employment, you may be required to complete and clear a multi-panel drug screening process.  This screening is in connection with requirements set by certain of the Company's customers, with which you may be working in this role, and will at all times be administered all applicable laws. 

Welldoc is an equal opportunity employer and prohibits discrimination and harassment of any kind. We offer an inclusive workplace and will not tolerate discrimination against any job candidate or employee due to age, race, religion, color, ethnicity, national origin, gender, gender identity/expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status or parental status.