Job Descriptions

Who we want:

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Position Summary

Under general direction, responsible for the leadership and directing of complex projects, which often require resources and functional integration.

Responsibility for all aspects of the project from initiation to completion.

Interfaces with all stakeholders affected by the project, including end users.

Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa.

Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access.

Partner with the business by driving regulatory processes and activities through strategic projects.

What you will do:

• Leads the execution and delivery of the EMEA registration plan for assigned franchises (Joint Replacement and Mako) and building high quality regulatory dossiers to achieve timely regulatory approvals and renewals.
• Primary contact with assigned Stryker Design Divisions as a subject matter expert on market clearance and renewal activities across EMEA markets, ensuring ongoing market access in line with business strategy.
• Supports the execution of submission strategies / registration planning in EMEA in collaboration with RAQA management.
• Maintain active participation in product lifecycle management planning and associated RA execution.
• Build, implement and maintain effective product registration processes.
• Partner with International RA teams to promote sharing of best practice and leveraging of product documentation to accelerate market access.  
• Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RAQA management.
• Understanding of RA procedures and processes.
• Able to define and communicate project scope, goals and deliverables
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance
• Responsible to improve team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders
• Provides support to EMEA / Country RAQA teams as appropriate

What you will need:

• Level 8 Degree in any discipline
• Minimum of 4 years experience in Regulator Affairs

Skills

• Communication Skills
• Project management
• Teamwork Skills
• Effective Risk Mitigation

Experience

• 4+