Product Manager - MDR Data & AI Solutions

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Job Function:

Technology Product & Platform Management

Job Sub Function:

Technical Product Management

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Product Manager - MDR Data & AI Solutions role to be located in Raritan, NJ

Position Summary

The Med Tech R&D IT - Data and AI organization is seeking a highly experienced Technical Product Manager to lead the strategy, design, and delivery of MDR-compliant digital platforms and cloud-based solutions supporting global regulatory and manufacturing operations. This role operates at the intersection of product management, regulatory compliance, and cloud technology, owning the end-to-end lifecycle of MDR systems including regulatory submissions, data management, and platform integration.

Product Strategy & Roadmap

* Define and own the product roadmap aligned with regulatory and business priorities

* Drive AWS cloud platform strategy including roadmap and governance

* Translate business and regulatory needs into scalable product vision

Solution Design & Technical Leadership

* Lead architecture and design for MDR and Manufacturing IT systems

* Guide technology selection and solution trade-offs

* Ensure integration across global Med Tech systems

Product Delivery & Execution

* Own end-to-end delivery including scope, timelines, and releases

* Establish governance frameworks and manage risks

* Assess change impacts across releases

Platform Operations & Reliability

* Oversee service health of AWS-hosted platforms

* Lead incident management and root cause analysis

* Drive resiliency and observability practices

Regulatory Compliance & Quality

* Ensure adherence to GxP, MDR, and validated system requirements

* Maintain audit-ready documentation and validation artifacts

* Support regulatory inspections and compliance readiness

Continuous Improvement

* Drive improvements in platform performance and efficiency

* Optimize cloud cost and scalability

Stakeholder Management

* Act as liaison between MDR business and IT

* Align stakeholders across R&D, Regulatory, Quality, and IT

* Communicate roadmap and delivery updates

Qualifications

Required

* Bachelor's degree in engineering, Computer Science, Life Sciences, or related field

* 8-12+ years of experience in Med Tech, Life Sciences, or regulated environments

* Strong experience with MDR, GxP, or validated systems

* Experience managing cloud-based platforms (AWS preferred)

* Proven track record in technical product management, platform ownership, or program delivery

* Strong understanding of regulatory compliance, system validation, and audit processes

* Strong knowledge of AWS platform architecture and services including:

* Data & Analytics:
Amazon S3, AWS Glue, AWS Lake Formation, Amazon Athena, Amazon Data Zone

* Orchestration & Integration: AWS Step Functions, Apache Airflow (Amazon MWAA), Amazon API Gateway

* Infrastructure & Dev Ops:
Terraform, Jenkins

* Experience managing production service health at enterprise scale, including incident/problem management, RCA, resiliency design, and observability tooling (Cloud Watch, X-Ray, or equivalent).

Preferred

* Experience with MDR data platforms (EUDAMED, UDI, regulatory submissions)

* Familiarity with Med Tech R&D lifecycle (design → validation → submission → post-market)

* Experience in data platforms,…