This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee Field Action initiatives.

• Guide stakeholders in formulating strategies, communications, reporting, and gathering evidence.

• Assist in responding to inquiries from global regulatory authorities for medical devices.

• Assess quality standards in relevant regions and contribute to compliance strategies.

• Collaborate on compliance initiatives for Dexcom locations with quality responsibilities, including reviews of importer/distributor activities and projects for continuous improvement.

• Aid in internal and external audit processes.

⛳️ Requirements

• Generally requires a Bachelor’s degree.

• At least 8-12 years of relevant experience.

• Knowledge of ISO 13485, MDSAP, and EU MDR quality standards.

• Preference for familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa, South Korea, and/or Latin America.

• Experience in leading or participating in quality-related initiatives, including executing field actions, enhancing quality processes, and conducting/supporting audits.

• Capability to develop compliant processes while identifying efficient working methods.

• Ability to operate independently and collaboratively within an international, cross-functional team setting.

• Strong problem-solving skills, proactive learning abilities, and organizational proficiency.

• Exceptional communication skills.

• Willingness to travel 5-15% of the time.