Work Flexibility: Hybrid
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 customer’s 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 & before 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 – 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 years’ 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.
Travel Percentage: 10%
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