Senior Regulatory Compliance Specialist Medical Device
About The Position
Oracle Health is a suite of healthcare technology solutions designed to help organizations advance patient care, improve operational efficiency, and enhance caregiver experiences. Its offerings include electronic health records, population health tools, and data-driven insights for healthcare organizations. The Senior Compliance Specialist guides cross-functional teams on medical device quality system compliance, focusing on quality system support for CE marking processes and requirements under the EU Medical Device Regulation (EU MDR). The role supports conformity assessment procedures, technical documentation, medical device files, risk management, post-market surveillance, market access, audits, CAPA, monitoring regulatory changes, EU market authorization, quality objectives, HQMS data and metrics reporting, and supplier quality activities.
Requirements
- At least 5 years of relevant experience.
- Understanding of quality management system standards and risk management.
- Excellent written and verbal communication skills.
- Project management skills.
- Ability to adjust and adapt to changing priorities in a dynamic environment.
Nice To Haves
- BA/BS or advanced degree preferred.
Responsibilities
- Provide quality system support for conformity assessment procedures and medical device market access.
- Prepare technical documentation and develop and maintain medical device files.
- Support risk management and post-market surveillance.
- Coordinate and assist with internal and external audits, including Notified Body audits related to CE marking.
- Help manage corrective and preventive actions (CAPA).
- Monitor changing European regulatory requirements and act as a subject matter expert on EU market authorization.
- Maintain up-to-date knowledge of relevant regulations.
- Collaborate with cross-functional teams to meet quality objectives.
- Analyze HQMS data and metrics for management reporting.
- Support supplier quality management activities.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability
- Long-term disability
- Life insurance and AD&D
- Supplemental life insurance for employees, spouses, and children
- Health care and dependent care Flexible Spending Accounts
- Pre-tax commuter and parking benefits
- 401(k) savings and investment plan with company match
- Flexible or accrued vacation, depending on eligibility and position
- 11 paid holidays
- Paid sick leave
- Paid parental leave
- Adoption assistance
- Employee Stock Purchase Plan
- Financial planning and group legal benefits
- Voluntary auto, homeowner, and pet insurance
- Potential eligibility for bonus and equity
- Volunteer programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
