Project Manager

Project Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Duration- 24 months+ Actual Title: QA/RA Project Manager (EU MDR) This position will be responsible for project management for programs with regulatory consequences and significant cross functional support for the Surgical Innovation (SI) business unit (BU). The initial focus will be overall execution and implementation of the European Medical Device Regulation (EU MDR) on a business unit level, but may include other programs in the future. The Project Manager will provide direction and leadership to a cross-functional team including subject matter experts (SME) and requires the ability to drive strategic initiatives while also managing tactical activities and communicating effectively with a large group of stakeholders. The Project Manager is accountable for alignment with corporate PMO and work stream strategies to drive harmonization across the BU / MITG / Client where appropriate. The Project Manager is responsible for ensuring team commitments (scope, schedule and budget) are met and for communicating program status to senior leadership on a regular basis.

Qualifications

Education 8+ years with Bachelor's; or 6+ years with Master's in Regulatory Affairs, or a function familiar with technical files and medical device product development process BS/BA degree or equivalent degree in Business Management, Engineering, or other related field of study.

Experience & Skills

• Lean or Green Belt certified a plus, with solid PM implementation experience required.
• A minimum of 5 years of QARA and/or plant manufacturing or engineering experience, which includes a minimum of 5 years of demonstrated process improvement and project management success.
• Knowledge of current European medical device directives (MDD) and CE mark process
• Ability to work independently or collaboratively to determine and develop approaches to solutions
• Experience driving initiative and change management across a BU
• Excellent verbal, written communication and presentation skills; Experience delivering presentations at all levels in an organization
• Experience influencing stakeholders at multiple levels in an organization
• Experience with MS Project, Excel, PowerPoint, Word, SharePoint
• Demonstrated ability to work successfully in complex business and project areas, leveraging interpersonal skills and technical skills to optimize results
• Broad business knowledge and ability to link customer needs with business processes
• Strong analytical problem solving skills.
• Ability to support multiple projects and balance priorities.
• Ability to work independently and with all levels of managers, associates, and clients.
• Strong coaching, facilitation and organizational skills.
• Excellent oral / written communication and platform skills.