Senior RA Manager, EAR & CEOT in Cork, Ireland

Position Summary

Applies expert knowledge and understanding of RA / QA / PMS frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Ensure that all activities delegated to the Central Economic Operator Team (CEOT) by various Economic Operators are conducted in a timely and efficient way. Direct and contribute to initiatives within the organisation with groups engaged in the development of good regulatory practice and policy.

As the European Authorised Representative (EAR), act as a liaison between Stryker Legal Manufacturers of medical devices located outside Europe and European Regulatory authorities, in matters related to product regulatory and quality compliance.

Key Activities & Accountabilities

• Serve as Person Responsible for Regulatory Compliance (PRRC) for Stryker’s EAR as defined by the EU MDR with the responsibility of defining and implementing strategic plans to drive effective regulatory compliance in partnership with Stryker Legal Manufacturers.

• Serve as Management Representative for the EAR QMS under ISO 13485.

• Provide strategic direction, oversight and governance for processes related to Stryker’s EAR role in close collaboration with Legal Manufacturers, Economic Operators and global stakeholders.

• Develop and maintain QMS processes governing the role of the EAR and CEOT in regional and global compliance and product supply chain.

• Contribute to assessing Design Division and other Economic Operators’ compliance with applicable European Regulatory requirements.

• Participate in advocacy activities of a more advanced strategic nature within the Irish Medtech Association.

• Ensure timely and effective MDR verification on behalf of the Economic Operators involved in the product supply chain (EAR, Importer and Distributor). Ensure that these activities are performed in line with agreed associated KPIs.

• Maintain optimal EAR and CEOT organisational design, processes and related quality agreements to best serve business needs.

• As the EAR, actively engage with Design Divisions, Stryker Europe Commercial organisation and Corporate RAQA function to drive compliance to EU requirements and define and implement processes, procedures and workflows to meet these requirements.

• Represent Stryker in interactions with EU Competent Authorities and other regulatory bodies in the capacity of EAR.

• Responsible for registration of applicable devices with the Irish Competent Authority, as the EAR.

• Lead and direct meetings required to drive closure of regulatory and quality issues.

• Collects, organises and maintains files on local and regional regulatory intelligence.

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

• Acts as a subject matter expert on European regulatory compliance supporting the wider Stryker EMEA organisation.

• Identifies opportunities for continuous improvement and supports those activities across EMEA RAQA.

• Line management of the CEOT, driving team engagement and development.

• 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

• Act as RAQA Leader, reporting performance, risks and issues to leadership teams where applicable.

• Leads Third Party, Competent Authority or Notified Body audits related to MDR Economic Operator topics.

• Leads recruiting, selection, on-boarding and development of talent within EAR and CEOT to increase performance.

• Maintains a high level of team engagement and collaboration.

• Participate in integration of new acquisitions, ensuring integration of product portfolio within EAR and CEOT processes.

• Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for EAR and CEOT.

Education

BSc degree in relevant field. Advanced Degree preferred.

Master’s Degree or equivalent desired.

Experience

10 years’ experience. 5+ years supervisory experience.

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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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.