Senior Labelling Project Manager MDR

Teleflex Medical Europe
Employment Type
Not disclosed
Teleflex Medical Europe logo

This will be a fixed term role.

Job Purpose: 

The role of the Senior Labelling Project Manager, MDR is to lead MDR labelling projects with cross-functional management, core team, and stakeholders to achieve overall Labelling MDR project goals and objectives for the various portfolio products. 

This role will involve coordinating, planning and implementing activities with other project managers, BU Regulatory, Labelling team, Engineering, Manufacturing, Demand Planning/SCM, Logistics and Distribution, and Business Unit representatives. 

This person will effectively transition project management duties from other current acting project managers and own the project activities that drives the remediation through follow up revisions from notified body feedback and required changes. The successful candidate will utilize project management tools, processes and will manage critical situations and provide professional communication of project status to project core team members, global plant management, and other cross functional labelling team members.

Key Responsibilities: 

Key responsibilities will include (but are not limited to) the following:

•Pickup ongoing project management duties from assigned Project Manager in the execution / implementation, and closure of ongoing scope of Arrow brand label change management and if applicable other merged projects scope activities.

•Support peer MDR Labelling Project managers with on-going labelling remediation requirements per notified body response. 

•Plan, schedule, and control project activities for the labelling predecessor deliverables in preparation of redline edits per MDR requirements and/or CE mark removal requirements, update labelling, and execute successor tasks into manufacturing implementation.

•Lead (coordinate, facilitate, and motivate) the efforts of the individual, team, internal customer, and other resources associated with MDR Labelling project activities.

•Work in close collaboration with regulatory affairs management, labelling management, and cross functional team leads to drive project tasks through successful completion.

•Manage project scope, schedule, and communicate budget/expenses while maintaining quality as a top priority and balancing risks to meet project deadlines.

•Manage the communication and maintain solid collaboration with the labelling team lead and the manufacturing plant leads for a smooth transition of label design to production readiness state.

•Lead risk management activities within the project team.  Ensure risks are appropriately mitigated and coordinate contingency plans within labelling, regulatory, R&D, global operations, demand fulfillment teams.

•Present to the Sr. Director of Global Labelling, Plant Managers, department team managers on bi-weekly or monthly project status reports and escalate risks as necessary.

•Facilitate weekly meetings, take meeting minutes with action items, and follow up with core team leads and SMEs on expected deliverables.

•Maintain strong documentation of project plans, schedules, tracking metrics, and status reports.

•Create and maintain proper documentation and communication of project activities and deliverables to keep team members on-task to completion of their responsibilities.

•Maintain strong rapport with project core team, SMEs, and serve as a project advocate within the Morrisville organization.

•Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

Essential Skills / Experience: 

·Bachelor’s degree in engineering or business discipline or equivalent education/experience required.

·Minimum 5-year project management experience in a large or global operations organization.

·Minimum 2-years’ experience in labeling, regulatory, or quality assurance function for a medical device and/or FDA regulated industry.

·Highly desire knowledge and application of a disciplined project management process and SCRUM.

·Highly desire Six Sigma, CAPM or PMP certifications

·Experience with Project Management tools; i.e. MS Project, Planview, Smartsheets.

·Exceptional skills with MS Outlook, SharePoint, Excel, and Power Point presentation.

·Experience with Agile change management software and SAP (ERP system) preferred.

·Competencies in detailed planning, project coordination and task management, leadership, and organizational skills.

·Self-starter with minimal management oversite and self-motivated with a can-do attitude to drive projects to successful completion.

·Ability to produce and present clear, concise, and professionally written communications and presentations. 

·Strong analytical capabilities and business acumen. 

·Ability to grasp strategic concepts, strategy development skills, and highly complex internal and external dependences to mitigate risks relating to regulatory affairs and business revenue.

·Ability to lead and facilitate multiple activities and resources. 

·Demonstrated strong work ethic, integrity, and professional conduct. 

Key Relationships / Interfaces: 

·Regulatory Affairs

·Quality Management teams 

·Supplier Quality – MDR Operations Team

·Global Procurement 

·Buyers/ Purchasing Organisation 

·Suppliers of Finished Devices

Behaviours / Values: 

•Approachable and enthusiastic, flexible and adaptable.

•Ability to work off own initiative and as a team player. 

•Good organizational skills with cultural awareness and sensitivity 

•Good judgment and problem-solving ability & is capable of understanding the impact of decision making on both Teleflex Medical and their customers.

•Strong collaboration and influencing skills – both internally and externally

•Excellent communication skills – both written and verbal

•Goal orientated for customer and business objectives

•Coaching/mentoring skills

Travel Required: 10% 

Note: As with all positions, due to the dynamic nature of Teleflex Medical Business, key responsibilities will evolve and change over time. Teleflex is an equal opportunities employer.