Lead Specialist, RAQA

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 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. Fluent Portuguese is an advantage.