Description:
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
- 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:
- US 510(k), pre-submissions, LTF, MDDS change assessment
- Health Canada amendments
- CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations
- ROW: work with regional regulatory affairs teams to support in-country product classification, change assessment, registration and amendments
- You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.
- 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
- You will represent Regulatory Affairs on various cross-functional teams:
- 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.
- 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.
- You will create and revise procedures as needed. You will review and approve change orders and evaluate for submission requirements.
- You will perform other duties as assigned.
What Makes You Successful
- 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
- You have excellent writing skills in technical documentation. You have experience participating in a cross functional environment.
- 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.
- 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.