PM/SM - SAMD Software as a Medical Device Expert @ Pune

Direct Application Link :

Job Title: PM/SM - SAMD Software as a Medical Device Expert @ Pune

Company: ACPL for Pharma Client

Location: Pune - India

Experience Required: 12-20 years

Relevant Experience: 5 years

Key Skills: Scrum, Team Leadership, Healthcare Administration, Electronic Health Records (EHR)

Company Description

This is ACPL employee requirement to work with Client - IT/SW devision of Worlds's No. 1 Pharma Company in Pune.

Role Description

This is a full-time hybrid role located in Pune, India, with the flexibility to work partially from home. The PM/SM - SAMD (Software as a Medical Device) Software Expert will oversee project management activities, including scheduling and coordination, while ensuring effective collaboration between teams. Responsibilities include expediting processes, managing inspections, overseeing logistics, and ensuring that project deliverables align with defined requirements and timelines. The selected candidate will contribute to the strategic planning and execution of Software as a Medical Device-related endeavors.

Key Responsibilities:

1. Agile Management:

• Act as a Scrum Master for development teams, facilitating all Agile ceremonies (e.g., sprint planning, daily stand-ups, sprint reviews, retrospectives).
• Encourage and guide teams to adopt Agile principles, enabling high-performing and efficient workflows.
• Manage sprint backlogs, track team progress using Agile tools (e.g., Jira, Azure DevOps), and remove impediments to ensure smooth development processes.

1. SaMD Development Coordination:

• Collaborate closely with cross-functional teams, including software developers, quality assurance, regulatory affairs, and product teams, to support SaMD development.
• Ensure alignment with ISO 13485, IEC 62304, ISO 14971, and other applicable medical device software regulations.

1. Regulatory Documentation for SaMD:

• Oversee the creation, review, and management of SaMD documentation for regulatory submissions, ensuring compliance with EU CE Mark requirements and US FDA regulations.
• Coordinate with internal and external stakeholders to collect and compile evidence to support Technical Documentation Files (TDF) and Design History Files (DHF).
• Support audit readiness and interact with notified bodies, regulatory authorities, and auditors as needed.

1. Stakeholder Communication:

• Foster clear communication channels between internal teams, business stakeholders, and external partners.
• Act as the liaison to ensure that all requirements for SaMD are understood, tracked, and implemented as part of development processes.

1. Continuous Improvement:

• Drive Agile best practices and identify opportunities for process improvements.
• Conduct retrospectives and implement changes to improve team efficiency and product delivery.

Required Qualifications and Experience:

• Experience in Agile/Scrum:
• Certified Scrum Master (CSM) or equivalent certification (e.g., SAFe Scrum Master, PMI-ACP).
• Proven experience as a Scrum Master in technical/engineering teams, preferably in the healthcare or medical device industry.
• SaMD Expertise:
• Strong understanding of Software as a Medical Device (SaMD) development processes, including IEC 62304 (Software Life Cycle Processes) and ISO 13485 (Quality Management Systems).
• Familiarity with ISO 14971 (Risk Management for medical devices) and usability standards (e.g., IEC 62366).
• Regulatory Documentation:
• Hands-on experience preparing and managing SaMD documentation for EU CE Mark Technical Files and US FDA 510(k) or De Novo submissions.
• Familiarity with European Medical Device Regulation (EU MDR) and FDA's SaMD-specific regulatory frameworks.
• Technical Acumen:
• Familiarity with software development practices, version control systems, and SaMD-related toolchains (e.g., automated testing, configuration management tools).
• Technical background (e.g., degree in software engineering, computer science, or a related field) is a strong plus.
• Soft Skills:
• Strong interpersonal, organizational, and facilitation skills.
• Effective problem-solving and decision-making capabilities in a highly regulated environment.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience leading globally distributed teams in a regulated environment.
• Working knowledge of cloud-based SaMD solutions (e.g., AWS, Azure).
• Experience in post-market support activities, including vigilance and complaint handling for SaMD products.