Senior Regulatory Affairs Specialist

DexCom • San Diego, CA

11d • Remote

About The Position

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 we're 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 we've 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. We've already changed millions of lives and we're 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. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've 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: Join our world-class regulatory team and play a key role in bringing Dexcom’s innovative products to markets worldwide. As part of our dynamic, fast-paced team, you’ll have the opportunity to develop and apply advanced regulatory skills while contributing to our record of success. Help empower people across the globe to improve their health with Dexcom Continuous Glucose Monitoring (CGM) products. Collaborate across the organization to lead regulatory activities, including software-related projects and the review of advertising and promotional materials for our industry-leading Dexcom products. Where you come in: You will represent RA on core functional teams for post-market changes or 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: change notifications, technical file update and submissions, MDSS notifications and in-country registrations ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments You will provide direct support to RA team members reviewing and approving marketing claims, labeling, and advertising and promotional materials for life altering Dexcom products. You will closely partner with marketing, clinical, medical affairs, and other functions as you develop and approve impactful compliant advertising and promotional materials. You may 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 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 continuous improvement and adapting to change to ensure compliance, especially for global medical device regulations, design controls, change controls and risk management. You communicate and collaborate effectively with cross-functional partners to ensure alignment and timely review of quality documentation. You have current knowledge and experience in the review of Advertising and Promotional materials for medical devices.

Requirements

• 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.
• Excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions.
• Experience interacting with regulators.
• Passionate about continuous improvement and adapting to change to ensure compliance, especially for global medical device regulations, design controls, change controls and risk management.
• Communicate and collaborate effectively with cross-functional partners to ensure alignment and timely review of quality documentation.
• Current knowledge and experience in the review of Advertising and Promotional materials for medical devices.
• Effective verbal and written communication skills.
• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience.

Nice To Haves

• Experience using Veeva PromoMats is desired.

Responsibilities

• Represent RA on core functional teams for post-market changes or 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: change notifications, technical file update and submissions, MDSS notifications and in-country registrations ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
• Provide direct support to RA team members reviewing and approving marketing claims, labeling, and advertising and promotional materials for life altering Dexcom products.
• Closely partner with marketing, clinical, medical affairs, and other functions as you develop and approve impactful compliant advertising and promotional materials.
• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees