Manager Regulatory Affairs- Digital Health
Dexcom, Inc

Job Info

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Meet the team:

The Regulatory Affairs Manager will work with a team of specialists and program managers within and outside of the regulatory department to lead RA efforts for a variety of industry, research and other partners for Dexcom. We are a team of interdisciplinary medical device professionals who pride ourselves in providing regulatory subject matter expertise. We partner with business, software R&D, product, clinical and other teams to find innovative regulatory approaches in supporting Dexcom and partners' business objectives.

Where you come in:

• You are the subject matter expert on the regulatory classification and interoperability requirements for the portfolio of Dexcom products, including digital health components, wearables, hardware and software mobile applications, cloud-based software components and data integration solutions
• You will learn about the diabetes technology landscape and interoperable partner devices, including AID systems, algorithms, insulin pen/pumps and diabetes management software solutions
• You will represent regulatory affairs in internal and external cross functional meetings to advise and strategize the following:
  • Dexcom product regulatory classification and requirements
  • Global regulatory plan and strategy for future products
  • Pre and post-market regulatory support needs for partners
• You are responsible for regulatory strategy and execution of Dexcom digital health components to support global partnership activities. You will work with product and R&D teams to provide regulatory assessment for software device classifications, change impact assessment, complete any registration needs globally to meet business objectives.
• You will be the point of contact for partner related advertising and promotional activities, review Dexcom materials and help support commercial launches.
• You will also lead or support regulatory submissions, consultations and other discussions with global regulators on digital health topics, including the FDA, notified bodies, in-country representatives, distributors and other counsels
• You may manage and advise specialists for responsibilities outlined above.

What makes you successful:

• Your excellent communication skills, ability to interact efficiently with different functions spanning from R&D to commercial organizations within Dexcom, and with external partners
• You are well-versed in digital health products, including software development, change management, regulatory assessment in a regulated environment. You have excellent writing skills and experience interacting effectively with regulators.
• Your passion for bringing new digital health technology to a broader audience through innovative regulatory approaches
• You bring a thirst to learn about an ever-changing technology and regulatory landscape in the global environment, and a strong drive for results to ensure commercial timelines are met
• You have a successful track record or mentoring and managing a team

What you'll get:

• A front row seat to life changing CGM technology. 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.

Exempt Salary Details

The annual base salary range for this role is $105,800 to $176,300. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand

#LI-AP1

Experience and Education

• Typically requires a Bachelors degree with 8-12 years of industry experience.
• 2-5 years of previous management or lead experience.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-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 enable individuals with disabilities to perform essential functions.

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

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

UnitedHealthcare creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://transparency-in-coverage.uhc.com/.

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.

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