Description

Provide strategic input to and manage all activities related to the Medical Device Regulation implementation project, ensuring effective planning, monitoring and timely conduct of all required activities and achievement of all agreed milestones.

Partners with Medical Device Quality manager and Medical Device Manager, Regulatory.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

• Creation and maintenance of all relevant project documentation
• Develop overall project plan and conduct risk assessment.
• Direct the activities and manage the resources required to deliver the project to agreed timelines and quality targets
• Develop effective strategies for the project to meet agreed business goals
• Provide proactive advice and project management expertise to project team (role requires close collaboration with internal colleagues across the business)
• Effectively lead a project team to ensure that project objectives are met
• Monitor and communicate progress on project and resolve internal issues
• Act as liaison with internal stakeholders and champions as required to ensure appropriate input into project strategy and timely delivery of the project
• Providing status reporting to stakeholders according to an agreed communications plan.
• Develop, collect and report such project metrics as may be required by project steering committee

Requirements

Competencies

• Excellent verbal and written communication skills; good presentation skills with clear and convincing manner, and ability to tailor communication method to the audience
• Ability to motivate people to achieve common goals and encourage collaboration among team members while showing respect for the expertise and opinions of others
• Ability proactively to identify potential issues and to solve problems by assessing risks, consequences and pros/ cons of possible solutions
• Ability to be adaptable, work under pressure and to tight deadlines
• Proven time management skills and the ability to remain calm whilst managing multiple tasks, appropriately identify priorities, and manage work accordingly
• A self-motivated team player with drive and ambition
• Proven ability to use initiative and proactively think ahead
• Proficient in Microsoft Outlook, Word, Power Point, MS Project and Excel

This role has a key communication role between the Project Team, business lead(s) and the Steering Committee. The individual is required to have tact and discretion as well as the ability to complete tasks in a pro-active manner.

Skills and Experience

• Demonstrated matrix management and/or line management skills with demonstrable track record of delivering projects to desired objectives, on time and on budget. A formal project management qualification or equivalent an advantage.
• Demonstrated use of effective communication, influencing and negotiation skills with a wide variety of audiences, including senior management, to facilitate successful project implementation and effective issue resolution.
• Ability to simultaneously handle multiple responsibilities, priorities, tasks and projects of complex nature and to meet deadlines in a fast paced environment.

• Ability to provide operational leadership to achieve expedited project delivery. Operational leadership skills include delegation and supervision, planning, fostering team work, organizing and managing teams and sub-teams based on critical path activities in order to achieve an optimal balance between schedule, scope, cost and risk.

• Familiarity with use of project management software tools such as MS Project highly desirable
• Knowledge and experience of developing Medical Device requirements as it relates to Quality Management and regulatory processes.

Career history of working with cross-functional teams in an international pharmaceutical environment, with previous experience of medical devices desirable