Regulatory Affairs Specialist

Dexcom

Vilnius, Lithuania

Meet the team:

Join a dynamic Regulatory Affairs team that plays a critical role in ensuring compliance and supporting Dexcom’s growth across EMEA and LATAM. We’re passionate about collaboration, problem-solving, and making a positive impact in the fast-paced medical device industry. Our team thrives on innovation, teamwork, and a little fun along the way - we believe great results come from great people working together. Join us and help empower people across the globe to improve their health with Dexcom Continuous Glucose Monitor (CGM) products.

Where you come in:

You will be responsible for preparation and submission of regulatory documentation for international product marketing authorizations.
You will be responsible for reviewing and assessing post-approval changes.
You will be responsible for preparation, review and submission of amendments, supplements and variations to product marketing applications.
You will closely partner with Marketing, Medical and Legal teams as you review and approve advertising/promotional materials and marketing claims to provide regulatory strategy and compliance input.
You will be responsible for maintaining internal regulatory documentation files and systems.
You will maintain current knowledge of regulations and guidance as applicable by role.
You will represent RA on cross functional projects.
You will work onsite to develop a strong understanding of manufacturing processes and related inspections/tests, while collaborating with wider Regulatory Affairs colleagues to support change evaluations and impact assessments.

What makes you successful:

You have previous experience in the medical device industry with successful ROW submissions
You have strong technical, research and problem-solving skills
You can articulate complex ideas clearly both verbally and in writing.
Desirable that you have experience with advertising/promotional materials reviews and Veeva Promo Mats system.
You can effectively manage multiple projects and priorities.