Excelya

Data Scientist

• Collect, clarify, and document business requirements.
• Support functional understanding of data flows and in vitro applications.
• Perform functional testing on new VITRO product features.
• Conduct quality checks on the VITRO database and ensure data integrity.
• Write and update user guides, training materials, and business rules (FR/EN).
• Maintain documentation for deployments (DEV / UAT / PROD).
• Review and validate Master Data imported into different environments.
• Track changes and ensure consistency across versions.
• Apply data integrity rules and follow directives provided by internal Data Management leads.
• Collaborate with Agile product teams and contribute to sprint activities.

Data Manager

Medical writer

• **Your Mission:**
• - Lead the preparation and review of key medical device documentation, including **PMCF** plans/reports, **PSURs**, **CERs**, and **PMS** reports for class IIA, IIB and III medical devices.
• - Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation.
• - Provide expert medical and scientific input across projects, ensuring compliance with **MDR** requirements and supporting transitions **from MDD to MDR**.
• - Respond to regulatory authority queries with clear, evidence‑based medical justifications.
• - Collaborate with cross‑functional teams to support study‑related documentation (protocols, study reports) for **medical device projects**.
• - Participate in scientific meetings and stay updated on clinical and **regulatory developments in the medical device field**.

Senior Medical Writer – Medical Devices

Compliance

• Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
• We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
• This role is an exciting opportunity to join our dynamic and ambitious Regulatory Affairs team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth
• The position involves performing as **Local Regulatory Affairs Expert** providing consultancy services related to **marketing authorizations** and supporting regulatory activities for pharmaceutical products in Malta.
• Work in several aspects of regulatory affairs shall be expected, such as:
• · Provides local regulatory consultancy and expert advice related to Marketing Authorization (MA) applications and amendments**· Supports preparation, submission, and follow-up of MA applications and variations with local Health Authorities**· Manages ongoing regulatory activities for authorized products to ensure continuous compliance with national requirements**· Provides support for Decentralized Procedure (DCP) lifecycle management and national phase activities**· Reviews and ensures alignment of product information, labelling, and packaging with local regulatory standards**· Monitors national regulatory changes and communicates relevant updates to stakeholders**· Provides ad-hoc regulatory support and guidance as needed**· Collaborates closely with global and regional Regulatory Affairs teams to ensure consistency and compliance
• This position requires solid knowledge of regulatory requirements, strong communication skills, and the ability to work independently while liaising effectively with both local authorities and international teams.

Regulatory Affairs Member

Manager

• Serve as the environmental and ICPE reference within the HSE department and act as the interface with internal teams on these topics
• Conduct a diagnostic of environmental practices and propose a roadmap to implement an environmental management system aligned with ISO 14001 and integrated into the existing HSE system
• Define a structured action plan (milestones, indicators, priorities, governance) and contribute to the environmental initiatives of the CSR roadmap
• Create, update and distribute the environmental reference documentation
• Structure and oversee waste management (sorting, regulatory compliance, documentation, contractor audits and associated action plans)
• Provide operational support on environmental matters (organization of storage areas, internal communication, management of specific waste)
• Contribute to reporting of environmental indicators and maintain technological watch on waste treatment solutions
• Ensure environmental regulatory compliance and update the ICPE file when necessary
• Collaborate with HSE teams to identify regulatory gaps and implement corrective actions.

Environmental HSE Manager

Clinical Research

• Conduct site initiation, monitoring, and close-out visits.
• Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
• Communicate effectively with study sites to facilitate trial conduct and resolve any issues.
• Review and verify study-related documents and data to ensure accuracy and completeness.
• Monitor patient safety and data integrity throughout the study.
• Participate in preparation for audits and regulatory inspections.
• Provide regular updates to project managers and stakeholders on site progress and any challenges.

Clinical Research Associate

Systems Engineer

• Excelya recherche un dispositif médical innovant de classe III dans un environnement R&D exigeant et fortement réglementé.
• Nous recherchons un(e) Ingénieur(e) Système avec une dominante software pour rejoindre un projet stratégique dans le domaine des dispositifs implantables cardiovasculaires.
• Ingénierie système & exigences - Rédaction et structuration des exigences système et software
• Traduction des besoins utilisateurs en exigences techniques
• Gestion de la traçabilité des exigences
• Participation à l’architecture système (interaction hardware/software)
• Contribution aux revues de conception
• Développement & conformité réglementaire - Application du cycle en V
• Participation aux activités de Vérification & Validation (V&V)
• Contribution au Design History File (DHF)
• Travail en conformité avec : Règlement (UE) 2017/745
• ISO 13485
• ISO 14971
• IEC 62304
• Gestion des risques - Participation aux analyses de risques (AMDEC / FMEA / FTA)
• Analyse d’impact des modifications software

Ingénieur Système, Dispositif Médical – Classe III

• **Main Responsibilities:**
• - Provide regulatory advice on advertising and promotion of pharmaceutical products and medical devices across international markets.
• - Review and approve promotional materials to ensure compliance with local, regional, and international regulations.
• - Collaborate with cross-functional teams, including marketing, legal, and medical affairs, to develop compliant promotional strategies that resonate with diverse audiences.
• - Monitor and analyze changes in global regulatory requirements related to advertising and promotion, providing timely updates and guidance to stakeholders.
• - Engage with regulatory authorities and industry associations to maintain positive relationships and facilitate the approval process of promotional content.