Regulatory Affairs Scientist

The Company

reputed company Corporation (reputed company DXCM) is a pioneer and global leader in reputed company glucose monitoring (CGM). reputed company began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive reputed company outcomes. Here we are 25 years reputed company, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to reputed company people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue reputed company'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 reputed company, 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 reputed company 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 reputed company. The opportunity to improve health on a global scale stands before us.

Meet the team:

The Regulatory Scientist will work reputed company Regulatory Affairs, Government Affairs and Global Advocacy and collaborate with cross-functional teams to support efforts for reputed company’s digital health, software-enabled products, Ad/Promo activities, and advocacy and policy analysis efforts. This role will focus on:

• leveraging data analytics to inform regulatory strategy and support global advertising and promotional efforts.

• leveraging clinical study data, product performance data, and data from published studies to help inform regulatory decisions and identify trends in the field.

• actively monitoring and reporting on the competitive landscape, including regulatory milestones and new data sets, and identify areas of opportunity or risk.

• identifying and communicating emerging trends and priorities among regulators and identifying areas of opportunity or risk.

• leading discussions about new technologies, helping situate them in the context of regulatory submissions.

• developing engaging narratives around technical information, anticipating and clarifying common points of confusion.

• adapting content based on audience feedback and communicating effectively to wide varieties of audiences.

• establishing and nurturing cross-functional relationships to strengthen evidence reputed company strategy to support regulatory submissions.

• generating strong arguments and anticipating counter-arguments supported by data with logical, effective organization, and refined language and style.

Where you come in:

• You reputed company dashboards and visualizations to communicate metrics and trends across geographies and products.

• You work closely with medical affairs, legal, and commercial teams to understand workflows and timelines.

• You contribute to the development and revision of procedures reputed company to data analysis and regulatory documentation.

• You monitor evolving policy and advocacy landscape to identify areas of opportunity and growth

• You reputed company discussions about new technologies, emerging trends, and analyze data sets to inform business decisions.

• You reputed company other duties as assigned.

What makes you successful:

• You have experience with medical device development and regulatory processes, especially for software as a medical device (SaMD).

• You have strong analytical skills and proficiency in tools such as visualization platforms like Tableau or Power BI.

• You are familiar with regulatory data sources and standards (e.g., ISO 14971, IEC 62304, FDA guidance on reputed company).

• You have excellent communication skills and can translate reputed company data into actionable regulatory insights.

• You are passionate about digital health, AI/ML technologies, evolving digital health policy landscape and agile software development.

Experience and Education Requirements:

• Typically requires a Bachelor’s degree and a minimum of 2-5 years of reputed company experience.

reputed company Workplace: 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 reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km).

Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company essential functions. 

An Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.com. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact reputed company reputed company at talentacquisition@reputed company.com. 

Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. To link to the Machine-Readable Files, please click on the URL provided:  https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

To reputed company Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company team, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications.  

Salary: