Regulatory Affairs Specialist at Dexcom

Vilnius, Vilnius County, Lithuania -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

3648.75

Posted On

14 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Device Industry, Technical Skills, Research Skills, Problem-Solving Skills, Communication Skills, Advertising Review, Promotional Materials, Project Management, Compliance, Team Collaboration, Veeva Promo Mats, Documentation Management, Regulatory Strategy, Market Authorization, Post-Approval Changes

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. 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. 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. Experience and Education Requirements: Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent. Travel Required: 0-5% Flex Workplace: Your primary location will be your assigned Dexcom site, but you may work part of the week from a home office. You must live within commuting distance of your assigned Dexcom site (typically within an hour's commute). To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Monthly base salary for this position is from €2,953.75 to €3,648.75 gross. Final offer will depend on your qualifications, competencies, and professional experience.

Responsibilities

You will be responsible for the preparation and submission of regulatory documentation for international product marketing authorizations and reviewing post-approval changes. Additionally, you will partner with various teams to ensure compliance and maintain internal regulatory documentation files.