Regulatory Affairs and Quality Assurance Manager – MENA
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Job Summary
Regulatory Affairs and Quality Assurance Manager MENA
As a RAQA Manager with Stryker you will play a critical leadership role in driving regulatory and quality excellence across a dynamic and fast-growing region. Based in Dubai this position offers a unique opportunity to act as a strategic partner to the business while ensuring compliance and operational effectiveness across key markets such as the UAE Saudi Arabia Egypt. You will be at the forefront of shaping regulatory strategy supporting business growth and leading high-performing teams within a global matrix organization known for innovation and impact in healthcare.
What You Will Do:
Collect organize and maintain files on local regional and global RAQA intelligence
Identify the need for new regulatory procedures and SOPs and participate in their development implementation and continuous improvement across RAQA
Provide support to EMEA/Country RAQA teams as appropriate by defining and executing local RAQA strategy in alignment with EEMEA and local sites
Act as RAQA Leader reporting performance risks and issues to local leadership teams and other Stryker leadership teams where applicable
Define targets KPIs and performance objectives for RAQA within the local office
Maintain a high level of team engagement development and collaboration across the RAQA team in the local office
Lead the integration of new acquisitions ensuring RAQA systems integration within the local office and across EMEA depending on the integration strategy
Represent Stryker in regulatory working groups at local or regional trade associations identify needs for broader international collaboration and leads regulatory changes together with key internal and external partners
What You Need:
Required:
BSc degree in a relevant field
8 years of related experience including a minimum of 3 years of supervisory experience
Demonstrated knowledge and application of regulatory requirements including Medical Device Directive EU Medical Device Regulations Quality Systems and Post-Market Surveillance requirements as well as other international medical device regulations
Proven leadership skills including experience in managing remote team developing talent and managing complex multi-region projects within a matrix environment
Strong project and time management skills including writing coordination and execution of complex RA/QA/PMS activities
Fluency in English
Arabic language proficiency
Preferred:
Advanced degree or RAC certification
Diversity is important to us. We welcome applications from people regardless of their ethnic national or social origin gender disability age or sexual identity.
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Travel Percentage: 20%Required Experience:
Manager
Key Skills
About Company
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. Alongsid ... View more
