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:
1. Very good acquaintance and understanding of Post Market Surveillance procedures and processes.
2. Lead Project Management related to systems implementation & improvement - EUDAMED DATA BASE, MORE DATA BASE, TW, Power BI etc
3. Continue to get insight & expertise on systems management, come with the project proposals improvements
4. Make sure training & driving the team members to navigate confident into our systems in use or to be deployed
5. 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
6. Responsible for systems budget implementation/estimated financial & human resources needs
7. Ensure a common understanding by setting expectations in accordance with the project/system plan in order to align the stakeholders and team members
8. Able to define and communicate scope, benefits, requirements and deliverables, system/s will bring for the team & business
9. Lead the identification, assessment, monitoring, and closure of project/system risks
10. 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.
11. 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
12. 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.
13. Provides support to EMEA / Country RAQA teams as appropriate.
14. Acts as a regional subject matter expert
15. Increased participation within working groups (regional, corporate, divisions) on various projects to get a broader perspective on corporate and regional digital strategy
16. Generate adhoc analyses data and statistics as per the business & department needs
17. Take the lead role within BSI audit program
18. Expand experience on the most Important principles of communication at different stakeholders' level
19. EMEA SharePoint updates – Data access
20. Provides support to EMEA / Country PMS teams as appropriate
What you need:
21. BA or BS in Management or a related discipline (preferred), or equivalent.
22. Minimum of 5 years’ experience in Post Market Surveillance (PMS) and project/systems management.
23. Very good understanding of Post Market Surveillance procedures and processes.
24. In depth knowledge of the Medical Devices Directive/EU-MDR / Post Market in Surveillance regulations
25. Proven knowledge of ISO 13485 quality management systems
26. Prior divisional or site experience preferred.
27. Prior cross-site/division experience preferred.
28. Ability to analyze and resolve complex process and/or system issues of a broad scope using independent judgment.
29. Excellent interpersonal communication, collaboration, and negotiation skills.
30. Ability to build trusting relationships with mid-level management.
31. Demonstrated experience in presenting to executives.
32. Strong ability to clearly communicate information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions, and third-party distributors.
33. Active participation in the preparation of briefings and other informational documents.
34. Ability to generate and explain detailed proposals, schedules, financial data, objectives, and other documentation accurately.
35. High attention to detail and process awareness.
36. Strong analytical skills to consolidate and interpret data necessary for project execution.
37. Proficiency in using software tools such as PPM systems, MS Office, SharePoint, and Visio to maintain project records.
38. Fluency in English.
Travel Percentage: 10%