Product Manager – MDR Data & AI Solutions

Johnson & Johnson Innovative Medicine•Raritan, NJ

2d•$102,000 - $175,950•Hybrid

About The Position

The MedTech 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.

Requirements

Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field
8–12+ years of experience in MedTech, 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 & DevOps: Terraform, Jenkins
Experience managing production service health at enterprise scale, including incident/problem management, RCA, resiliency design, and observability tooling (CloudWatch, X-Ray, or equivalent).

Nice To Haves

Experience with MDR data platforms (EUDAMED, UDI, regulatory submissions)
Familiarity with MedTech R&D lifecycle (design → validation → submission → post-market)
Experience in data platforms, APIs, or digital transformation initiatives
Certifications in AWS, Agile, or Program/Product Management

Responsibilities

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
Lead architecture and design for MDR and Manufacturing IT systems
Guide technology selection and solution trade-offs
Ensure integration across global MedTech systems
Own end-to-end delivery including scope, timelines, and releases
Establish governance frameworks and manage risks
Assess change impacts across releases
Oversee service health of AWS-hosted platforms
Lead incident management and root cause analysis
Drive resiliency and observability practices
Ensure adherence to GxP, MDR, and validated system requirements
Maintain audit-ready documentation and validation artifacts
Support regulatory inspections and compliance readiness
Drive improvements in platform performance and efficiency
Optimize cloud cost and scalability
Act as liaison between MDR business and IT
Align stakeholders across R&D, Regulatory, Quality, and IT
Communicate roadmap and delivery updates

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
consolidated retirement plan (pension) and savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours