Regulatory Affairs Specialist
About the role
You will support developmental activities for Dexcom software products. You will develop regulatory strategies and prepare submissions in various countries (US, EU, Canada). You will collaborate with regional regulatory teams to develop global strategies as required. You will review and approve product and promotional labeling for software. You will represent Regulatory Affairs on various cross-functional software teams. You will review and approve software documentation and evaluate for submission requirements. You will take on additional projects and responsibilities as needed.
Requirements
- Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience
- Knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems
- Medical Device Software experience and/or knowledge, such as software development lifecycle, IEC 62304, and software classification
- Strong technical writing, editing, and analytical skills
- Ability to work independently and with cross-functional teams
- Ability to thrive in a fast-paced environment and adapt quickly to changing priorities
- Proficiency in problem solving, proactive learning, organization, and excellent communication skills
Qualifications
- Previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation is preferred
Benefits
- A front row seat to life changing CGM technology
- A full and comprehensive benefits program
- Growth opportunities on a global scale
- Access to career development through in-house learning programs and/or qualified tuition reimbursement
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve
Pay
$71,600.00 - $119,300.00
Schedule
Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). Travel required: 5-15%.