Regulatory Affairs and Quality Assurance Manager – MENA

Why join Stryker?

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.
• Please note that the internal job title may differ from the ad title.
• 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.