Project Management

Roles & Responsibilities

• Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment initiatives.
• Develop and maintain integrated project plans, timelines, milestones, and progress tracking mechanisms.
• Coordinate reviews of technical documentation, including design history files, verification and validation documentation, risk management files, labeling, and other regulatory deliverables.
• Partner with Regulatory Affairs, R&D, Quality, Medical Affairs, Manufacturing, and Marketing to assess documentation readiness for regulatory submissions.
• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.
• Drive development and execution of remediation plans to address identified gaps and ensure submission readiness.
• Manage project risks, dependencies, and issues through proactive planning and escalation when needed.
• Schedule, organize, and facilitate team meetings, reviews, and working sessions.
• Record and publish meeting minutes, decisions, action items, and key project updates.
• Monitor progress against project milestones and follow up with functional owners to ensure timely completion of deliverables.
• Maintain accurate project documentation, dashboards, and status reports for leadership and stakeholders.
• Communicate project status, risks, mitigation plans, and key decisions to cross-functional leadership teams.
• Ensure project activities are conducted in compliance with applicable quality systems, design control requirements, and regulatory expectations.
• Support continuous improvement initiatives related to technical documentation processes, regulatory readiness, and project execution.
• Apply project management best practices and tools to drive alignment, accountability, and project success.

Experience Required

• Bachelor\'s degree in a scientific, engineering, regulatory, or related discipline.
• Minimum of 3-5 years of experience in project management within a regulated industry.
• Experience working in medical devices, in vitro diagnostics (IVD), biotechnology, life sciences, or related regulated environments.
• Demonstrated experience leading cross-functional initiatives involving multiple stakeholders and competing priorities.
• Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes.
• Experience coordinating complex projects involving documentation review, compliance assessments, or remediation activities preferred.
• Familiarity with global regulatory frameworks applicable to medical devices and IVD products is preferred.
• Experience supporting regulatory submissions, product registrations, or compliance programs is a plus.
• Project Management Professional (PMP) certification is a plus but not required.

Skills & Certifications

• Strong project planning, organization, and execution skills.
• Ability to manage multiple projects and priorities simultaneously.
• Excellent meeting facilitation, written communication, and presentation skills.
• Strong analytical, problem-solving, and risk management capabilities.
• Demonstrated ability to influence and drive accountability in a matrix organization.
• Proven ability to track and manage action items, dependencies, and project deliverables.
• Detail-oriented with a commitment to quality and compliance.

Eligibilities & qualifications

• Proficient with Microsoft Office applications including Excel, PowerPoint, Word, and Project.
• Experience with project management, document management, or product lifecycle management tools is preferred.
• Demonstrated ability to effectively communicate with technical, regulatory, and business stakeholders.