Manager RAQA MENA

September 10, 2024

Stryker

الرياض

FULL TIME

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Position Summary

Develops and applies comprehensive knowledge and understanding of the Regulatory and Quality frameworks, legislative requirements, processes and procedures in the EEMEA distribution organization Dubai

Key Activities & Accountabilities

Collects, organises and maintains files on local, regional, and global RAQA intelligence.
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Identifies opportunities for continuous improvement and supports those activities across RAQA.
Performs based on established targets, KPIs and objectives for RAQA.
Provides support to EMEA / Country RAQA teams as appropriate.
Act as RAQA Leader, reporting performance, risks and issues to local leadership teams and other Stryker leadership teams where applicable.
Acts as a subject matter expert to the local business
Lead teams to support regulatory processes for market access of products
Lead the development and deployment of new systems and procedures locally
Leads Third Party, Competent Authority or Notified Body audits within the local organization
Supports continuous improvement activities across RA, QA and PMS activities within the local office
Defines targets, KPIs, performance objectives for RAQA within the local office
Leads recruiting, selection, on-boarding and development of talent within the local office to increase performance
Maintains a high level of team engagement and collaboration across the RAQA team in the local office
Monitors team performance and takes action to keep the team on track by providing appropriate coaching and feedback to others
Team management and encouragement to ensure high performance in accordance with our values
Collaboratively works to set meaningful performance objectives and identify milestones for goal achievement
Leads integration of new acquisitions, ensuring RAQA systems integration within the local office and across EMEA dependent on integration strategy.
Represents Stryker in local industry association as RAQA subject matter expert in advocacy activities of a more advanced technical and / or tactical or strategic nature
Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations
Define and execute local RAQA Strategy in alignment with EEMEA and local site
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

Education

BSc degree in relevant field. Advanced Degree preferred.
RAC preferred.

Experience

8 years’ experience. 3+ years supervisory experience

Knowledge/Competencies

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
Demonstrate technical knowledge of medical device regulatory and quality requirements
Demonstrated ability to effectively prioritize and manage multiple project workloads
Demonstrated ability to lead and develop employees and building effective teams
Demonstrated leadership skills
Experience with recruiting, hiring and developing talent
Demonstrated process improvement skills
Demonstrated ability to manage complex and multi-region projects within a matrix environment
Demonstrated ability to collaborate effectively with and lead cross-functional teams
Influence across the organization
Coordinate, support, and lead technical and scientific RA / QA / PMS activities.
Undertaking assignments that are broad in nature, requiring originality and ingenuity
Ability to take unreviewed action or decisions
Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions and third-party distributors.
Leads meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support.
Prepares briefings and other information documents.
Communicates information and advises on RA / QA / PMS requirements to other departments and business units.
Engages in communication with regulators and other key stakeholders on routine and complex matters with minimal supervision.
Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
Connects and relates well with people who think and act differently than oneself.
Embraces scrutiny and accepts feedback as opportunity to learn and improve.
Preparation of RA / QA / PMS metrics for reporting purposes.
High attention to detail and process consciousness.
Strong IT skills, including Microsoft Office.
Fluent in English (Arabic language skills are a plus).

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 Med Surg, 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.