Senior Regulatory Affairs Specialist

DexCom • San Diego, CA

1d • 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 for our industry-leading Dexcom products.

Requirements

• Proficiency in US and EU medical device requirements, including but not limited to design control and quality system regulations, regulatory submission requirements, and labeling requirements.
• Direct experience with supporting regulatory submissions, such as 510(K)s, new license applications, license amendment applications, or technical documentation files.
• Working knowledge of international medical device standards, such as ISO 13485 and ISO 14971.
• Strong technical writing, editing, and analytical skills.
• Must work well independently and within a cross-functional environment.
• Must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.

Nice To Haves

• Knowledge of Health Canada medical device regulatory requirements is a plus.
• Familiarity with IEC 60601-1 or ISO 10993-1 a plus.

Responsibilities

• Represent regulatory affairs on various cross-functional teams supporting product changes, design control activities, and compliance issues.
• Participate in planning, preparation, submission, and maintenance of various marketing applications for the United States (US) and Canada (Q-Subs, 510(k)s, IDEs, license applications and license amendments), and technical documentation files for the European Union (EU).
• Review and approve change orders, and assess associated regulatory impacts, to support design or manufacturing changes.
• Author Letters to File (LTFs) and Notified Body Change Notifications.
• Review and approve product labeling and marketing materials, as needed, to ensure compliance with regulatory requirements.
• Provide regulatory support as needed for various post-market activities, including quality audits and regulator inquiries.
• Perform other duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior