Sr Manager, RAQA

• Customised according to RA / QA / PMS pillars and country specific responsibilities.
• Collects, organises and maintains files on local, regional, and global RAQA

• Identifies the need for new regulatory procedures, SOPs, and participates in

• Identifies opportunities for continuous improvement and supports those activities

• Performs based on established targets, KPIs and objectives for RAQA.
• Leads EMEA / Country RAQA teams as appropriate.
• Monitors team performance and takes action to keep the team on track by providing

• Team management and encouragement to ensure high performance in accordance

• Collaboratively works to set meaningful performance obectives and identify

• Act as RAQA Leader, reporting performance, risks and issues to local leadership teams

• 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

• Supports continuous improvement activities across RA, QA and PMS activities within

• Defines targets, KPIs, performance objectives for RAQA within the local office
• Leads recruiting, selection, on-boarding and development of talent within the local

• Maintains a high level of team engagement and collaboration across the RAQA team in

• Leads integration of new acquisitions, ensuring RAQA systems integration within the

• Represents Stryker in local industry association as RAQA subject matter expert in

• Liaison with the local business in manufacturing and Design Divisions to ensure

• Demonstrated 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
• Demonstrated 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 on business critical matters
• Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.
• Leads meetings with regulatory agencies, internal and external audits and other stakeholders.
• 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 both routine and business critical matters.
• Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organisation.
• 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

Stryker