lavori da Technical in località United States

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

• 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.
• Fluent in English (Arabic language skills are a plus).