Senior Project Manager, Post Market Surveillance, EMEA

**Position Summary**
At Stryker patient safety is a primary concern, and as PMS/Vigilance group within the RAQA function it is a must to ensure compliancy to all regulatory requirements to safeguard prevention of patient risks.
Partnering the business by meeting and exceeding customeru2019s expectations
Partnering with associated Governing and Regulatory & Certification Authorities
Develops and applies intermediate knowledge and understanding of the PMS frameworks, legislative requirements, processes and procedures in the EMEA distribution organization.
**What you will do:**
Very good acquaintance and understanding of Post Market Surveillance procedures and processes.
Lead Project Management related to systems implementation & improvement - EUDAMED DATA BASE , MORE DATA BASE , TW, Power BI etc
Continue to get insight & expertise on systems management, come with the project proposals improvements
Make sure training & driving the team members to navigate confident into our systems in use or to be deployed
Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project before & after a system to be used by the Post Market Surveillance teams
Responsible for systems budget implementation/estimated financial & human resources needs
Ensure a common understanding by setting expectations in accordance with the project/system plan in order to align the stakeholders and team members
Able to define and communicate scope, benefits, requirements and deliverables, system/s will bring for the team & business
Lead the identification, assessment, monitoring, and closure of project/system risks
Manage changes to the system in use or to be use, scope, timing & costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
Responsible for assembling a team to work with, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely system deployment - having in consideration no direct reporting line cooperation
Measure system/s performance using appropriate tools and techniques in order to monitor the useability , any variances, perform any required corrective actions, and communicate to all stakeholders.
Provides support to EMEA / Country RAQA teams as appropriate.
Acts as a regional subject matter expert
Increased participation within working groups (regional, corporate, divisions) on various projects to get a broader perspective on corporate and regional digital strategy
Generate adhoc analyses data and statistics as per the business & department needs
Take the lead role within BSI audit program
Expand experience on the most Important principles of communication at different stakeholders' level
EMEA SharePoint updates u2013 Data access
Provides support to EMEA / Country PMS teams as appropriate
**What you need:**
BA or BS in Management or a related discipline (preferred), or equivalent.
Minimum of 5 yearsu2019 experience in Post Market Surveillance (PMS) and project/systems management.
Very good understanding of Post Market Surveillance procedures and processes.
In depth knowledge of the Medical Devices Directive/EU-MDR / Post Market in Surveillance regulations
Proven knowledge of ISO 13485 quality management systems
Prior divisional or site experience preferred.
Prior cross-site/division experience preferred.
Ability to analyze and resolve complex process and/or system issues of a broad scope using independent judgment.
Excellent interpersonal communication, collaboration, and negotiation skills.
Ability to build trusting relationships with mid-level management.
Demonstrated experience in presenting to executives.
Strong ability to clearly communicate information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions, and third-party distributors.
Active participation in the preparation of briefings and other informational documents.
Ability to generate and explain detailed proposals, schedules, financial data, objectives, and other documentation accurately.
High attention to detail and process awareness.
Strong analytical skills to consolidate and interpret data necessary for project execution.
Proficiency in using software tools such as PPM systems, MS Office, SharePoint, and Visio to maintain project records.
Fluency in English.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer u2013 M/F/Veteran/Disability.