Regulatory Project Manager

Description:

Essential Duties & Responsibilities:

• Lead cross functional scientific and technical teams in all aspects of project initiation, planning, execution, monitoring and closure for programs assigned

• Lead teams in timely resolution of complex problems, including development of technical solutions, project plans, resourcing plans and budgets

• Accountable for core team performance, creation and management of project schedule, execution of the project, and budget commitments and spend

• Interacts through program updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders

• Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies

• Manage all financial aspects of assigned projects, from initiation through close, which may include capital expenditures, functional expenses, and program positioning

• Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes

• Work within the guidelines of project management, standard performance metrics, and regulatory guidelines to apply best practice Project Management skills, methodologies and standards (such as PMBOK)

• Maximizes business results through continuous improvement in organization's ability to execute programs from identification through implementation

• Leads core team to identify and implement continuous improvement

Qualifications

• Expertise in all aspects of project and program management

• Self-motivated/driven, good interpersonal skills and experience in analyzing complex problems as well as driving high performing teams

• Must have ability to lead cross-functional teams

• Excellent oral/written communication and presentation skills

• Understanding of Good Manufacturing Practices, Good Laboratory Practices and product development process requirements

• Strong leadership and financial acumen skills

• Proficiency with scheduling software such as MS Project

• Ability to create and maintain project deliverables such as project timelines, meeting minutes, status reports etc.

• PMP (Project Management Professional) certification desired

Education and/or Experience

• Minimum of a Bachelor’s degree required preferably in an Engineering or Science or equivalent discipline. MS/MBA preferred

• 5 years of demonstrated success leading multi-site, global or enterprise-wide programs in the medical products industry including 3-4 years of project management experience

• EU MDR experience is a plus