Senior Regulatory Affairs Specialist

6 days ago

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Dexcom

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Continuous Glucose Monitoring • Medical Devices • Diabetes • Decision Support • Data

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• 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. Regulatory Affairs Specialist 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. • You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment CE-marked products under EU MDR. • You will work closely 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 are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

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. • 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.

Benefits

• 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.