Lead Specialist, RAQA

Position Summary

Develops and appliesintermediate 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 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.