Work Flexibility: Hybrid

Sea uno de los primeros solicitantes, lea la descripción completa del puesto a continuación y luego envíe su candidatura para que sea considerada.
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

-

- Project management and time management skills, writing, coordination, and execution of more complex PMSand RAQA items.

- Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements.

- Coordinate, support, and lead technical and scientific PMS and RA QA activities.

- Facilitate meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support.

- Preparation of PMS and RA QA metrics for reporting purposes.

- Strong IT skills, including Microsoft Office.

- Fluent in English and Spanish. xqbhyrx Fluent Portuguese is an advantage.

Travel Percentage: 10%

#J-18808-Ljbffr

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