Meet the team:Dexcom's Quality Compliance team leads company quality initiatives and ensures 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 growth around the globe - join us and help drive best practices!
Where you come in: - You will be the responsible coordinator for Field Action activities, including leading stakeholders to develop strategy, communications, conduct reporting, and complete evidence gathering.
- You will support responses to inquiries from global medical device regulatory bodies.
- You will review quality requirements in applicable geographies and contribute to Dexcom strategies to achieve and maintain compliance in support of Dexcom's growth.
- You will collaborate on compliance activities for Dexcom sites with quality obligations (ex. Review of Importer/Distributor activities, continuous improvement projects, etc.).
- You will support internal audits 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, South Korea, and/or Latin America is preferred.
- Your experience includes leading or participating in quality initiatives, such as implementing field actions, implementing quality process improvements, and conducting/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.
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: 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
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
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.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
Salary:
$100,700.00 - $167,900.00
#DexcomUS
