Regulatory Affairs Senior Associate Health

Hybrid
Regulatory Affairs Specialist
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. 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. 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. 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.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.
If you join our team you will be supporting the growth and expansion of Continuous Glucose Monitoring (CGM) System.
You will collaborate with in-country regulatory representatives, develop regulatory strategies, and prepare regulatory submissions for India and other APAC countries.
You will help create, review, and approve product labeling, including IFUs, packaging, etc. You will represent Regulatory Affairs on various cross-functional teams and provide strategic input and technical guidance on regulatory requirements in the APAC region.
You will provide regulatory guidance to the software development team in our Bengaluru office.
You will review advertising and promotional materials to ensure they comply with local requirements.
You will assess the regulatory impact of proposed design and manufacturing changes and carry out the necessary regulatory actions.
Provide regulatory support for internal and external audits.
You bring knowledge of India and international regulatory requirements including medical device submission requirements, labeling and promotion regulations, quality control, and medical device quality systems.
You have Medical Device Software knowledge, such as software development lifecycle, IEC 62304, and software classification.
You have strong technical writing, editing, and analytical skills.
You must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.
Having previous experience with regulatory submissions in India is preferred.
Learn about our brave #dexcomwarriors community.
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.
Travel Required

• Experience And Education Requirements
• Typically requires a Bachelor's degree and a minimum of 5 – 8 years of related experience

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