Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
The Sr. Regulatory Affairs Specialist will work within regulatory affairs and with cross functional teams to lead RA efforts for Dexcom's SaMD products. The Sr RAS will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, cloud-based solutions and cybersecurity initiatives. The Sr RAS will work with software, algorithm development R&D, quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards.
Where you come in:
You are the RA representative on core functional teams for global software regulatory classification, change management, regulatory submissions including:
US 510(k), pre-submissions, LTF, MDDS change assessment
CE-marked products under EU MDR: change notifications, technical file update, MDSS notifications and in-country registrations
ROW: work with regulatory bodies or in-country representatives for device classification, registration and amendments
You will work with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements
You will represent RA in assessment of global cybersecurity and data privacy initiatives. You are responsible to advising on regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.
What makes you successful:
Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory strategy
You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions. You have experience interacting with regulators.
You are passionate about digital health products in a regulated environment, strong understanding or mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies.
You have effective verbal and written communication skills
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.
Travel Required:
5-15%
Experience and Education Requirements:
Bachelor's degree with a minimum of 5 years of relevant experience in medical device industry in functions such as software engineering, regulatory affairs, software quality, digital health product management
A minimum of 2 years of regulatory affairs experience required
Advanced degrees, such as a master or PhD in STEM areas desirable and may substitute for years of 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.
Meritain, an Aetna Company, 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://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
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