Sr Quality Compliance Specialist

Dexcom

Athenry, Ireland

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 growth across EMEA and LATAM – join us and help drive best practices in our region.

Where you come in:

You will review applicable quality requirements in EMEA and LATAM geographies 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 collaborate on Field Action activities, if applicable, including strategy, communications, reporting and evidence gathering.
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 field actions 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.
Travel Required: 5-15%