Product Manager – MDR Data & AI Solutions
$102,000–$175,950 year
On-site · Raritan, New Jersey, United States
Job Summary
Lead MDR data & AI platform product strategy, roadmaps, and delivery; MDR compliance, regulatory submissions, and cloud-based platforms (AWS) supporting regulatory and manufacturing operations. Own end-to-end lifecycle of MDR systems including regulatory submissions, data management, and platform integration. Define product roadmap aligned with regulatory and business priorities; drive AWS cloud platform strategy; lead architecture and design for MDR and Manufacturing IT systems; oversee end-to-end delivery, governance, and risk management; ensure audit-ready documentation, validation artifacts, and regulatory inspections readiness; manage stakeholder alignment across R&D, Regulatory, Quality, and IT; optimize platform performance, cost, and scalability.
Required Qualifications
- 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).
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