Project Manager

Description:

**Role is remote - PA preferred however candidate can be located anywhere in the US.

The post-market surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all Sleep & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and notified bodies, and creating the data required to drive business critical decisions at the executive level.

In this role, you will develop project plans and lead projects to track and direct activities to achieve project objectives while balancing schedule, cost, quality, and requirements. This role interfaces with all elements of the quality management system, Sleep & Respiratory Care business, global Philips businesses and markets, regulators, and notified bodies and necessitates ensuring compliance in a fast-paced, changing global regulatory environment.

You are responsible for

• Formulating project plans, in consultation with management and other impacted parties

• Organizing the resources to be used (quality, time, allocation, budget and information)

• Identifying project risks (i.e. specs, costs, planning, etcetera) and developing risk mitigations, defining corrective actions, and driving projects to closure

• Coaching and directing project team members, both technically and organizationally in accordance with the project plan (specification, quality, time, money, information)

• Gathering and reporting project performance and progress information (e.g., quality, status, time, and money) to senior management and to the project team

• Ensuring that there is an effective transfer and archiving of the project results and the associated knowledge

• Ensuring quality of deliverables

• Managing internal and external stakeholders

• Deploying process improvements and supporting a culture of continuous improvement

You are part of

To succeed in this role, you’ll need a customer-first attitude and the following

• Bachelor's Degree in appropriate field of study or equivalent work experience

• Medical device/pharmaceutical experience preferred

• 5+ years of experience in Project Management leading global efforts.

• Project Management Professional (PMP) is highly desired

• Project Manager with expert level experience managing global programs consisting of multiple projects at once

• Act as a leader beyond their immediate authority, function and/or business

• Deliver complex solutions with complex regulatory considerations

• Translate instructions and be fluent in the subject matter of the program, so as to hold conversations with both Quality and non‐Quality team members of all skill levels.

• Proven working experience in project management and leading continuous improvement projects

• Training in Lean Principles, Problem Solving and Kaizen facilitation

• Strong problem solving, analytics and critical thinking skills to evaluate data from multiple sources and coalesce into end-to-end systems analysis & interactions

• Excellent written and verbal communication skills

• Solid organizational skills including attention to detail and multitasking skills

• Strong working knowledge of Microsoft Office

FDA requirements CFR 820, 821

Basic understanding of ISO 13485

Experience w/ recalls a plus