Dexcom Deutschland GmbH · 8 hours ago
Regulatory Affairs Specialist
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$72K/yr - $119K/yr
2+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes and empower individuals to manage their health. The Regulatory Affairs Specialist will work with cross-functional teams to support regulatory efforts for software products, including assessments, submissions, and compliance with various regulations.
Medical Device
Responsibilities
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
Qualification
Required
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
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
Preferred
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
Benefits
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.
Company
Dexcom Deutschland GmbH
Die 1999 gegründete Dexcom, Inc.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase