Staff Quality Compliance Specialist

Benefits

Additional Information

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: Dexcom's Quality Compliance team leads the company's quality initiatives, ensuring Dexcom maintains good standing with global medical device regulatory bodies. We develop and implement processes that allow us to operate in compliance with applicable regulations, guidance documents and standards across the world. Our team balances rigor and pragmatism - we are passionate about collaborating as a team to implement ways of working that are both efficient and compliant. We are expanding our Quality Compliance team to support Dexcom's Quality Management System evolution. Where you come in: You will review applicable quality requirements and contribute to Dexcom strategies to achieve and maintain compliance. You will perform gap analyses on Dexcom's existing procedures and records. You will participate in the development and implementation of updates and improvements, as required. You will support compliance activities for Dexcom sites with quality obligations (ex. EU Importer/Distributor activities, EUDAMED registrations, etc.). You will Translate complex technical, quality, and operational information into clear, regulator-ready narratives. Support other functions in resolving quality systems issues and concerns. You will support internal and external audits. What makes you successful: You have experience with ISO 13485, MDSAP and EU MDR quality requirements. Additional familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa and/or Latin America is preferred. Your experience includes participation in quality initiatives, such as implementing new processes and supporting audits. You enjoy developing compliant processes and identifying efficient ways of working. You work well independently, as well as within an international and cross-functional team environment. You are proficient in problem solving, proactive learning, organization, and have excellent communication skills. Ability to manage multiple complex documents under aggressive regulatory timelines What you'll get: 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. Travel Required: 0-5% Experience and Education Requirements: - Typically requires a Bachelor's degree and a minimum of 8-12 years of related experience. - At this level a graduate degree may be desirable with 4 years of related experience Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment w