Senior Quality & Regulatory Affairs Specialist EMEA

• Quality Management, Project Management experiences, Medical Device
• Experiences, Pharmaceutical (GDP) experience is a plus
• MDR /IVDR Regulations/ ISO 13485
• Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus

• Bachelor's degree in Life Sciences, Pharmacist, Biomedical Engineering, Business management or a related field.

Specialised Knowledge and Skills:

• Knowledge and understanding of Quality Management Systems and Project Management
• Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
• Solution oriented, problem-solving attitude, pragmatic, high adaptability and flexibility
• Ability to work in a matrix, regional environment with different departments and countries
• English speaker
• Good communication skills and stakeholder management

Supports EMEA-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Global Distribution Group Henry Schein Sites in EMEA.

• Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.
• Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up and related documentation on identified issues and support countries in implementing solutions.
• Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up on decided actions with related functional / country QA/RA Lead.
• Support and assistance to Exec. Director QA & RA EMEA and the EMEA QA/RA Team
• Support to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
• Maintenance of eQMS and Quality Document Management Tool
• Oversight of change control activities and CAPA follow-up, timely closure
• Provides support to the country QA/RA Teams in Quality related topics to ensure compliance according GDP and MDR.
  • Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects and product launch activities
  • Support roll-out eQMS implementation in identified countries. o Inspection readiness initiatives and to roll- of required tools o Conduct and oversee quality training and compliance communications.
  • Assits PRRC and EC Rep responsibilities such as adverse event reporting, post-market surveillance and FSN management
  • Other tasks and projects as needed

• Job holder based in any country in EMEA
• Home based - ready to travel regularly (up to 30%)

• Balances a sense of urgency of time pressures with adherence to all regulatory requirements.
• Sensitive in dealing with confidential Information
• Demonstrates advanced oral and written communication skills
• Must be fluent in written and spoken English