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MDR - Project Manager
Ref No.: 18-27623
Location: North Haven, Connecticut
Start Date / End Date: 06/04/2018 to 04/30/2019
Company: Artech Information Systems
Job Title: MDR - Project Manager
Location: North Haven, CT
Duration: 10+ months
Job ID: 18-27623
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 / Healthcare 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.
Preferred skills & experience:
  • Lean or Green Belt certified a plus, with solid PM implementation experience required.
  • Knowledge of current European medical device directives (MDD/AIMDD) and CE mark process
  • 5 years of QA/RA and/or plant manufacturing or engineering experience, which includes a minimum of 5 years of demonstrated process improvement and project management success.
  • 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.
  • BS/BA degree or equivalent degree in Business Management, Engineering, or other related field of study.
  • 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.
Rajiv Maruthi