Technical Import Manager (Quality & Regulatory Manager EMEA)
1 day ago
Valencia
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. Acts as Technical Import Manager for Spain and is responsible in this role for ensuring that all imported medical products comply with strict European Union (EU) regulations and Spanish national laws (AEMPS). Provides support for coordinating the Henry Schein Brand registration and Henry Schein Products product launch activities in EMEA. Provides operational support Regulatory Affairs in Spain by facilitating regulatory document compliance according to different markets regulatory requirements and Henry Schein’s economic operator role as importer or distributor. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System., • To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting., • Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions., • Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead., • Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions., • Driving & supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives., • Provides support to the PRRC of the EC Rep in Germany for Henry Schein Products., • Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed., • Managing post-market surveillance (PMS), handling reporting obligations (vigilance/incidents), and liaising with authorities, essentially guaranteeing product safety and compliance throughout its lifecycle on behalf of the PRRC., • Provides operational support to Regulatory Affairs by facilitating regulatory document compliance according to different markets regulatory requirements and Henry Schein’s economic operator role as importer or distributor to support HSPG product launch and registration activities in EMEA., • Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR., • all imported products have the required CE marking, declarations of conformity, and technical documentation required by EU Regulations 2017/745 (MDR) and 2017/746 (IVDR)., • Manage the prior operating license for importing and ensure products are registered on the CCPS portal (Spanish Medical Device Marketing Notification) and EUDAMED., • Coordinate with customs brokers to facilitate clearance, manage tariff codes, and handle documentation to prevent import delays., • Verify that imported products meet quality standards and specifications, including proper labeling and translation of instructions for use (IFU) for the Spanish market., • Act as the technical contact for monitoring products after they are placed on the market, collecting data, and reporting incidents to the Spanish Authorities. In addition to the essential duties and responsibilities listed above, all positions are also responsible for: • Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures., • Adhering to Company policies, procedures, and directives regarding standards of workplace behaviour in completing job duties and assignments. Physical Activities: • Job holder based in any country in EU, • Home based – ready to travel regularly across European sites (up to 30%) QUALIFICATIONS: Experience: • Quality Management, Project Management experiences, Medical Device Experiences, Pharmaceutical (GDP) experience is a plus, • Support Communicating with Regulatory Bodies, • MDR /IVDR Regulations/ ISO 13485, • Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus Education: • Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field. Specialised Knowledge and Skills: • Knowledge and understanding of Quality Management 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 Other: • 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
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