Work Flexibility: Hybrid

Position Summary
Develops and applies intermediate knowledge and understanding of the Post-Market Surveillance (PMS) and RAQA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation.

Key Activities & Accountabilities

Executes PMS and RA QA activities in line with defined procedures and processes.

Collects, organises and maintains files on local, regional, and integral RAQA intelligence.

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

Suggest opportunities for continuous improvement and supports those activities across RAQA.

Performs based on established targets, KPIs and objectives for PMS and RAQA.

Provides support to EMEA / Country RAQA teams as appropriate.

Support local RAQA Leader to collect data relevant for reporting performance, risks and issues to local leadership teams

Acts as a subject matter expert to the local business

Support the development and deployment of new systems and procedures locally





Supports continuous improvement activities across PMS and RAQA and activities within the local office

Supports recruiting, selection, on-boarding and development of talent within the local office to increase performance

Supports integration of new acquisitions, ensuring RAQA systems integration within the local office

Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations

Identify training needs and deliver training at any Organisational level

Update and develop training material in the relevant knowledge domain

Education

BSc degree in relevant field. Advanced Degree preferred.

Experience

4+ years experience.

Proven experience in managing Post-Market Surveillance (PMS) activities in compliance with Regulation (EU) 2017/745 ( European Union) and relevant local regulatory requirements in Spain and Portugal.

Knowledge/Skills

Pro

📌 Lead Specialist, Raqa (Madrid)
🏢 Stryker
📍 Madrid