EU MDR Compliance Lead — Medical Device

Oracle

Montpelier (VT)

On-site

USD 74,000 - 148,000

Full time

6 days ago

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Benefits offered by this job

Medical, dental, vision insurance

Short-term disability

Long-term disability

Life insurance & AD&D

401(k) plan with company match

Paid time off & vacation accrual

Sick leave & parental leave

Employee stock purchase plan

Flexible spending accounts

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. You will support conformity assessment, technical documentation, and post-market surveillance to enable market access for EU products.

Responsibilities include audits, CAPA, regulatory trend monitoring, and collaboration with suppliers.

Qualifications

5+ years of relevant experience in quality/compliance for medical devices or health tech.
Understanding of quality management system standards (QMS) and risk management.
Excellent written and verbal communication skills.
Project management skills with ability to manage multiple priorities.
Ability to adapt to changing priorities in a dynamic environment.

Responsibilities

Provide quality system support through conformity assessment procedures and technical documentation.
Develop and maintain medical device files, risk management, and post-market surveillance for market access.
Coordinate and assist with internal and Notified Body audits related to CE marking.
Monitor compliance with EU regulatory requirements and serve as SME on EU market authorization.
Collaborate with cross-functional teams and analyze HQMS data for reporting.