Job Description

Job Description

Job Description

This is a high-impact, dual-focus contract role, requiring deep experience in the Medical Device and Combination Product industry. The role serves two key functions: operating as a Project Manager to drive the complex development program timeline execution, and acting as the QMS Specialist to ensure compliance with Roche Quality Systems.

This role is critical to ensuring successful execution of complex medical device and combination product programs through strong project management discipline and detailed timeline oversight. The position combines end-to-end project planning and coordination with support for Quality Management System (QMS) activities, enabling alignment between program execution and regulatory expectations.

In addition to driving integrated timelines, cross-functional coordination, and milestone delivery, the role supports QMS processes to help ensure that internal systems, documentation, and personnel qualifications meet global health authority requirements. This dual focus strengthens both operational execution and compliance, reducing risk and supporting audit readiness.

The Opportunity

You will manage complex projects across the development pipeline—from initial design to post-approval—while managing the regional business and compliance activities for the Device Development - Business Operations & Compliance Support. This role requires a unique blend of independent project leadership and the ability to manage project teams in a cross functional and matrix organization.

Core Responsibilities

Project Management & Execution:

• Strategic Planning: Translate device strategy into actionable plans, defining "inspection-ready" Design & Development Plans.
• End-to-End Management: Lead a range of projects including development pipelines, line extensions, and technology initiatives.
• Team Performance: Foster high-performing team dynamics, facilitating efficient decision-making, issue resolution, and cross-functional collaboration.
• Governance & Business Gates: Navigate teams through business process stage-gates and support technical advisory or governance committee reviews.

Compliance & Quality Management System Support:

• QMS Implementation: Drive implementation, maintenance, and continuous improvement of the Quality Management System (QMS) including the tracking of metrics
• Records Management: Manage Design History Files (DHF) and document repositories to ensure accuracy, completeness, and regulatory compliance.
• Audit Readiness: Manages audit and inspection readiness, including preparation for internal audits and Health Authority inspections, and oversees timely remediation of findings.

Operations & Continuous Improvement:

• Risk Mitigation: Proactively identify project and compliance risks, developing robust contingency and mitigation plans.
• Process Excellence: Lead business process continuous improvement initiatives by applying lessons learned and optimizing PM tools.
• Budget & Resources: Forecast and monitor team resources, project costs, and budget tracking.

Qualifications & Skills

• Education: B.S. degree in Engineering, Technical Field, or a related discipline.
• Experience: At least 12 years in the Pharmaceutical or Medical Device industry.
• • Minimum 5–6 years specifically in devices or combination products.
  • Proven experience in drug/device development and commercialization.
• Regulatory Expertise: Extensive knowledge of EU MDR, FDA 21 CFR Parts 210, 211, & 820 (including 820.30 design controls), and ISO 13485.
• Project Management: Proficiency in PM best practices and software; PMP certification is considered a significant asset.
• Leadership: Excellent professional presence with the ability to interact at all organizational levels and work with little to no supervision.

Work Environment & Logistics

• Location: SSF Onsite role.
• Travel: May travel once or twice a year with external partners and headquarters.
• Flexibility: Ability to interact across global time zones as required and work during global hours (7 am - 10 am Pacific)
• Contract Duration: approx 8 Months (For 2026)

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