Lead Specialist, RAQA

Job description

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%