Post Market Surveillance Coordinator

Oracle • United States,

6d • $87,000 - $178,100 • Remote

About The Position

The Post-Market Surveillance Coordinator supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch. This role helps ensure that post-market signals are captured, assessed, and tracked, in accordance with regulatory requirements and internal procedures as part of the quality system. This role will manage and coordinate analysis of post-market product feedback, complaints, adverse events, incidents, field reports, and other safety or performance issues for trend analysis and PMS reporting obligations. The Post-Market Surveillance Coordinator will lead a review of post-market surveillance processes and drive continual process improvement to maintain compliance to global market requirements. You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a Post Market Surveillance Coordinator who is collaborative, a creative problem solver, and dedicated to excellence in their work.

Requirements

• Ability to keep up with the fast-paced environment of software development and an evolving regulatory landscape.
• Collaborative
• Creative problem solver
• Dedicated to excellence in their work.

Nice To Haves

• BA/BS or advanced degree preferred
• 6+ years' experience in quality systems, post-market signaling, real world evidence tracking, regulatory reporting (or 4+ years with Master's)
• Experience acting as a lead to resolve issues
• Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• Experience leading process development
• Expertise in continual improvement and risk management
• Experience with advanced root cause analysis methods
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent
• Experience authoring submissions (510k, EU Technical Documentation, etc.) required
• Experience with sustaining and new product development is ideal
• Experience interacting with regulators preferred
• RAC, CQE, CPPS, or CQA certifications desired
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations
• Excellent written and verbal communication skills
• Ability to adjust and adapt to changing priorities in a dynamic environment
• Ability to perform in a fast-paced and continually evolving business environment

Responsibilities

• Supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch.
• Ensures that post-market signals are captured, assessed, and tracked, in accordance with regulatory requirements and internal procedures as part of the quality system.
• Manages and coordinates analysis of post-market product feedback, complaints, adverse events, incidents, field reports, and other safety or performance issues for trend analysis and PMS reporting obligations.
• Leads a review of post-market surveillance processes and drives continual process improvement to maintain compliance to global market requirements.

Benefits

• Flexible medical
• Life insurance
• Retirement options
• Volunteer programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree