Product Owner

Pacer Group; Gurugram District; Sur place; INR 1 200 000 - 2 000 000; Plein temps

Résumé du poste

Pacer Group is seeking an expert in medical data management and regulatory documentation to support its product development and compliance programs. The role focuses on data systems, process design, and alignment of user stories with market needs and roadmaps.

The candidate will contribute to CE marketing, FDA submissions and other country approvals, applying GMP/GCP and 21 CFR Part 11 best practices to ensure compliant medical devices.

Qualifications

• Experience creating medical data management, data transfer and data storage systems including relevant standards.
• Specialist in business/system analysis and process design, leveraging up-to-date knowledge of applicable tools and techniques and imparting their knowledge to the wider Product Owner team.
• Ensure User Stories and product requirements meet the market needs and align to the Product/Technical Enabler Roadmap.
• Creating medical devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals.
• Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant.

Responsabilités

• Deliver medical data management, transfer and storage solutions adhering to applicable standards.
• Lead business/system analysis and define process designs to support product roadmaps.
• Develop and validate user stories and requirements aligned with market needs.
• Prepare documentation (technical files) for CE, FDA 510(k) and other regulatory approvals.

Connaissances

Medical data management

Data transfer

Data storage

Business analysis

System analysis

Process design

User stories

Product Owner team collaboration

Description du poste

Experience creating medical data management, data transfer and data storage systems including relevant standards

Specialist in business/system analysis and process design, leveraging up-to-date knowledge of applicable tools and techniques and imparting their knowledge to the wider Product Owner team

Ensure User Stories and product requirements meet the market needs and align to the Product/Technical Enabler Roadmap

Creating medical devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals

Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant