Post Market Surveillance Coordinator
Not Disclosed•Full-TimeRemote
location_onUnion Street Northeast, Salem, Marion County, Oregon, 97311, United States
About the Team
Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions for healthcare providers, payers, pharmaceutical companies, medical device manufacturers, and clinical research organizations. We offer a range of products including AI/ML solutions, cloud-based platforms, data analytics, and electronic health records. Our mission is to help organizations improve patient outcomes, lower costs, and accelerate innovation by leveraging technology to streamline operations and make more informed decisions.
In a landscape where global technological developments and healthcare regulations are changing at an unprecedented rate, our regulatory affairs professionals are essential. We need experts who are deeply steeped in the public and private levers impacting the industry, capable of navigating complex laws and policies to keep our organization competitive.
About the Role
The Post-Market Surveillance Coordinator plays a key role in driving Oracle's success in the healthcare and life sciences sector. This position supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch. You will ensure that post-market signals are captured, assessed, and tracked in accordance with regulatory requirements and internal procedures.
You will manage and coordinate the analysis of post-market product feedback, complaints, adverse events, incidents, and field reports to support trend analysis and reporting obligations. This role involves leading reviews of post-market surveillance processes and driving continual process improvement to maintain compliance with global market requirements. You will work primarily with Oracle Health & Life Sciences business units while interacting with all Oracle business units selling products to the health and life sciences industries.
This is a fast-paced role requiring an individual who can adapt to the evolving regulatory landscape and the rapid pace of software development. We are looking for a collaborative creative problem solver dedicated to excellence who can keep up with dynamic priorities.
Hiring Process
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Equal Opportunity
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
We are committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, please contact us at accommodation-request_mb@oracle.com or call 1-888-404-2494 in the United States.
About Oracle
Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. With AI embedded across our products and services, we help customers turn that promise into a better future for all. True innovation starts when everyone is empowered to contribute. We encourage employees to give back to their communities through our volunteer programs and offer competitive benefits that support our people with flexible medical, life insurance, and retirement options.
Work location
Work model: Remote
Union Street Northeast, Salem, Marion County, Oregon, 97311, United States
Salem, Oregon
Key Responsibilities
- check_circleManage and coordinate analysis of post-market product feedback, complaints, adverse events, and field reports
- check_circleLead review of post-market surveillance processes to drive continual process improvement and compliance
- check_circleDesign cross-functional processes to generate safety and performance data for trend analysis and early-warning signals
- check_circleSupport clinical evaluation and post-market surveillance through systematic literature surveillance and data integration
- check_circleEnsure proper analysis of product quality, safety, and reliability issues with effective communication to management
- check_circlePrepare and provide monthly reports to trend key quality measures as part of the post-market surveillance system
- check_circleCoordinate across Quality, Marketing, Product Development, Clinical, and Regulatory staff to support the surveillance system
- check_circle
Requirements
- verifiedBA/BS or advanced degree preferred
- verified6+ years experience in quality systems or 4+ years with Master's
- verifiedExperience authoring submissions (510k, EU Technical Documentation)
- verifiedRAC, CQE, CPPS, or CQA certifications desired
- verifiedExperience with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820
- verifiedAbility to work within US
Nice to Have
Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience with sustaining and new product development. Experience interacting with regulators. RAC, CQE, CPPS, or CQA certifications.
Benefits & Perks
check_circleMedical, dental, and vision insurance including expert medical opinioncheck_circleShort term disability and long term disability coveragecheck_circleLife insurance and AD&D coveragecheck_circleSupplemental life insurance for Employee, Spouse, and ChildHealth care and dependent care Flexible Spending Accounts
Similar Job Opportunities
Skills, education and keywords
Skills: Iso 13485, Iso 14971, Iec 62304, 21 CFR Parts 210, 21 CFR Parts 211, 21 CFR Parts 803, 21 CFR Parts 820, Rac, Cqe, CPPS.
Education: Master's degree preferred (reduces experience requirement).
Frequently asked questions about Post Market Surveillance Coordinator at Oracle
What does a Post Market Surveillance Coordinator at Oracle do?expand_more
Day-to-day, the Post Market Surveillance Coordinator at Oracle will manage and coordinate analysis of post-market product feedback, complaints, adverse events, and field reports; lead review of post-market surveillance processes to drive continual process improvement and compliance; design cross-functional processes to generate safety and performance data for trend analysis and early-warning signals; and support clinical evaluation and post-market surveillance through systematic literature surveillance and data integration.
What are the requirements for this Post Market Surveillance Coordinator role?expand_more
To qualify for the Post Market Surveillance Coordinator at Oracle position, applicants should have: BA/BS or advanced degree preferred; 6+ years experience in quality systems or 4+ years with Master's; Experience authoring submissions (510k, EU Technical Documentation); RAC, CQE, CPPS, or CQA certifications desired; Experience with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820; and Ability to work within US.
Where is the Post Market Surveillance Coordinator role at Oracle located?expand_more
Post Market Surveillance Coordinator at Oracle is based in Union Street Northeast, Salem, Marion County, Oregon, 97311, United States. This is a remote role.
Is this Post Market Surveillance Coordinator job remote, hybrid, or on-site?expand_more
Oracle has listed this Post Market Surveillance Coordinator role as remote.
How much experience is required for this Post Market Surveillance Coordinator role?expand_more
Post Market Surveillance Coordinator at Oracle typically requires 6+ years of relevant experience at the senior level.
What skills do you need for the Post Market Surveillance Coordinator role at Oracle?expand_more
Key skills for Post Market Surveillance Coordinator at Oracle include Iso 13485; Iso 14971; Iec 62304; 21 CFR Parts 210; 21 CFR Parts 211; 21 CFR Parts 803; 21 CFR Parts 820; and Rac.
What education is required for Post Market Surveillance Coordinator at Oracle?expand_more
Educational requirements for this role: Master's degree preferred (reduces experience requirement).
What category does the Post Market Surveillance Coordinator role belong to?expand_more
Post Market Surveillance Coordinator at Oracle is part of the it job category on Recrutus.