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 global 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 PMS and 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. Fluent Portuguese is an advantage.
Travel Percentage: 10%
