Work Flexibility: Hybrid
What You Will Do:
• Collects, organizes and maintains files on local, regional, and global RAQA intelligence.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation as well as opportunities for continuous improvement and supports those activities across RAQA.
• Provides support to EMEA / Country RAQA teams as appropriate by defining and executing local RAQA Strategy in alignment with EEMEA and local site
• Act as RAQA Leader, reporting performance, risks and issues to local leadership teams and other Stryker leadership teams where applicable.
• Defines targets, KPIs, performance objectives for RAQA within the local office
• Maintains a high level of team engagement, development and collaboration across the RAQA team in the local office
• Leads integration of new acquisitions, ensuring RAQA systems integration within the local office and across EMEA dependent on integration strategy.
• Represent Stryker in Regulatory working groups at local or regional Trade Associations, Identify needs for broader international collaboration and lead regulatory changes together with key internal and external partners
What You Need:
Required:
BSc degree in relevant field
8 years of related experience with min 3+ years of supervisory experience
Project management and time management skills, writing, coordination, and execution of more complex RA / QA / PMS items
Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements, as well as other international requirements pertaining to the medical device industry
Leadership skills with the experience of developing talent and manage complex and multi-region projects within a matrix environment
Fluency in English
Preferred
Advanced / RAC Degree
Arabic language proficiency