Quick summary
- Work type
- Remote
- Location
- Remote
- Salary
- $87,000–$178,100 / yr
- Posted
- 15 days ago
Market check
Salary context
How this pay compares to similar roles
This role pays less than 82% of similar roles. Most pay $151,206–$218,037 — the shaded band above. At the midpoint, this role pays about $133k versus about $185k for comparable roles.
Based on 240 similar postings.
Employer
About Oracle
Oracle Corporation is a leading multinational technology company specializing in database software, cloud computing, and enterprise software.
Oracle currently has 731 open roles on FindRole.
Listed pay typically runs $97,500–$209,500 across 557 roles with salary data.
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At a glance
TL;DR · Post Market Surveillance Coordinator
As a Post-Market Surveillance Coordinator at Oracle's Health & Life Sciences Legal and Compliance Group, you will play a crucial role in ensuring product safety and compliance by monitoring, evaluating, and documenting post-market signals for medical devices. Your day-to-day responsibilities include managing feedback, complaints, adverse events, and field reports to identify trends and drive process improvements. You will collaborate with cross-functional teams such as Quality, Marketing, Product Development, Clinical, and Regulatory staff to maintain a robust surveillance system that complies with global regulatory requirements. Ideal candidates have 6+ years of experience in quality systems, post-market signaling, and real-world evidence tracking, along with expertise in ISO standards and medical device regulations. This role demands strong problem-solving skills, the ability to lead process development, and adaptability in a fast-paced environment where digital transformation is key.
Skills
What you'll do
- Manage and design processes for post-market surveillance activities.
- Support clinical evaluations by integrating real-world data into regulatory submissions.
- Identify trends and early-warning signals through systematic literature reviews.
- Drive continual improvement to ensure compliance with global regulations.
- Facilitate corrective or preventative actions based on product performance issues.
- Prepare monthly reports on key quality measures for post-market surveillance.
- Coordinate across departments to support a robust post-market system.
What we're looking for
- 6+ years of experience in quality systems, post-market signaling, real-world evidence tracking, and regulatory reporting.
- Demonstrated ability to lead issue resolution and apply structured problem-solving methods.
- Expertise in continual improvement, risk management, and advanced root cause analysis.
- Experience authoring medical device submissions (e.g., 510(k), EU Technical Documentation).
- Knowledge of quality management systems and relevant regulations (ISO 13485, IEC 62304, 21 CFR parts 803, 820).
- Ability to adapt to changing priorities in a fast-paced and evolving business environment.
- Experience with software as a medical device (SaMD) or equivalent in the medical device industry.
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