Regulatory Affairs and Quality Assurance Manager – MENA

Work Flexibility: Hybrid

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
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Employment Type : Full-Time
Experience: years
Vacancy: 1