Regulatory Affairs Specialist
About The Position
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: Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from biological and physical sciences to engineering, political science to biostatistics, pharmacology to law just to name a few. Our degrees include Bachelor’s, Master’s, Ph.D.’s, JD’s and more. With our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. We’re closely connected with QA, Clinical, IT, and Global Business Solutions (GBS) under the same Executive Vice President. At our quarterly onsite gatherings, some of our pastimes include story sharing, cooking and baking, social events and other team-building activities. If you join our team you will be supporting the growth and expansion of Dexcom’s Continuous Glucose Monitoring (CGM) Systems. Where you come in: 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
- 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 well independently and with cross-functional teams.
- Ability to thrive in a fast-paced environment and adapt quickly to changing priorities.
- Proficient in problem solving, proactive learning, organization, and have excellent communication skills.
- Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.
Nice To Haves
- Previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation is preferred.
Responsibilities
- Support developmental activities for Dexcom software products.
- Develop regulatory strategies and prepare submissions in various countries (US, EU, Canada).
- Collaborate with regional regulatory teams to develop global strategies as required.
- Review and approve product and promotional labeling for software.
- Represent Regulatory Affairs on various cross-functional software teams.
- Review and approve software documentation and evaluate for submission requirements.
- Take on additional projects and responsibilities as needed.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
