Regulatory Affairs Specialist

Dexcom • San Diego, CA

4d • Remote

About The Position

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. The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to support RA efforts as part of Dexcom’s MLR review process (medical/legal/regulatory). The Regulatory Affairs Specialist will be responsible for review of advertising and promotional materials to ensure compliance to applicable regulations. The Regulatory Affairs Specialist also supports coordination cross functionally to facilitate online and offline review meetings with authors, reviewers/approvers for timely content approval in support of business needs. The RA specialist performs librarian duties as directed to maintain accurate updates to the advertising and promotional library.

Requirements

• Experience with regulated medical device industry, and experience in Advertising & Promotional labeling requirements
• Excellent writing and verbal communication skills, strong attention to detail, highly organized, and experience managing projects within a cross functional environment.
• Knowledge of 21 CFR regulations, EU MDR
• Interested in the medical device industry, diabetes care, business system best practices
• Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.
• Regulatory Affairs experience is preferred.
• Advanced degree in may substitute for years of experience

Responsibilities

• Support review of advertising and promotional material in accordance to internal procedures as part of the MLR review process.
• Act as SME for Dexcom’s products and regulatory requirements for promotional activities
• Provide guidance to material authors and reviewers on regulatory and internal policy requirements.
• Help facilitate alignment of global product claims across regional SMEs
• Help support process improvement by working with cross functional team to make changes to current process pain points and optimize review efficiency
• Monitor changes with applicable US and international regulations and standards.
• Provide summaries for these changes to inform compliance needs and best practices for advertising and promotional review.
• Create reports & metrics to provide visibility to marketers, reviewers and management on process efficiency.
• Perform other duties as assigned.

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