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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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:The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to support RA efforts for Dexcom’s software products and components. The Regulatory Affairs Specialist will be responsible for support change assessments for software products, including mobile applications, cloud-based software solutions, internal software development tools and validation efforts.  The RA specialist will perform regulatory impact assessment under guidance and support regulatory submissions and registration activities.  Where you come in:<ul><li>You participate on behalf of regulatory affairs on core functional teams to understand design changes, support risk assessment activities, and support regulatory classification, change assessment, and regulatory submissions including:<ul><li>US 510(k), pre-submissions, LTF, MDDS change assessment</li><li>Health Canada amendments</li><li>CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations</li><li>ROW: work with regional regulatory affairs teams to support in-country product classification, change assessment, registration and amendments</li></ul></li><li>You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.</li><li>You will work closely with other regulatory team members to help streamline change assessment activities across geographies to help support timely global software feature releases</li><li>You will represent Regulatory Affairs on various cross-functional teams:<ul><li>You will contribute to the development of the project plan and other deliverables.  You will represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management, and other required documents.  You will participate in Design Reviews as appropriate.</li><li>You will work with SW development, engineering, architect, quality and cybersecurity teams to understand upcoming design changes and new software/architecture development efforts.  You will also work closely with SW quality teams to help support adoption of internal design/development tools, including required validation activities.</li><li>You will create and revise procedures as needed.  You will review and approve change orders and evaluate for submission requirements.</li></ul></li><li>You will perform other duties as assigned.</li></ul>What makes you successful:<ul><li>You have experience with medical device design and development processes. You have working knowledge of design control requirements, SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively support regulatory impact assessment</li><li>You have excellent writing skills in technical documentation. You have experience participating in a cross functional environment.</li><li>You are passionate about the medical device industry, digital health products in a regulated environment, working knowledge of mobile/web development, AI/ML technologies, analytics and agile software development methodologies.</li><li>You have effective verbal and written communication skills</li></ul>What you’ll get:<ul><li>A front row seat to life changing CGM technology. <a href="https://www.dexcom.com/warriors" target="_blank">Learn about our brave #dexcomwarriors community</a>.</li><li>A full and comprehensive benefits program.</li><li>Growth opportunities on a global scale.</li><li>Access to career development through in-house learning programs and/or qualified tuition reimbursement.</li><li>An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.</li></ul>Travel Required:<ul><li>5-15%</li></ul>Experience and Education Requirements:<ul><li>Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience, in medical device industry in functions such as software engineering, regulatory affairs, software quality, digital health product management preferred.</li><li>Regulatory Affairs experience is preferred. Advanced degree in a STEM area such as engineering, biological science, computer/data science is desirable and may substitute for years of experience</li></ul>Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.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. 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:  <a href="https://protect-us.mimecast.com/s/fufTCyPOPqFWlgBzhMXJ2t?domain=health1.meritain.com" target="_blank">https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&amp;brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&amp;lock=true</a>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.  Salary:$71,600.00 - $119,300.00

Dexcom

Regulatory Affairs Specialist San Diego, California

Dexcom

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