Device Development Assurance Scientist

1100 Mylan Pharmaceuticals Inc.; Dublin; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Bonus scheme

Pension

Work-life balance initiatives

Career progression opportunities

Job summary

Viatris recherche un Scientist Assurance Développement Dispositifs pour piloter les activités de gestion des risques et assurer la conformité ISO 14971.

Vous collaborerez avec les équipes Développement, Clinique et Qualité pour garantir des produits sûrs et efficaces, et vous soutiendrez les soumissions réglementaires et les contrôles de changement.

Qualifications

• Expérience dans une industrie réglementée (Dispositifs médicaux, produits combinés ou pharmaceutiques).
• Connaissance des contrôles de design et des systèmes de management de la qualité (QMS).
• Connaissance d’ISO 14971 et IEC 62366 serait un avantage.

Responsibilities

• Diriger et soutenir les activités de gestion des risques tout au long du cycle de développement.
• Maintenir la documentation de gestion des risques conforme aux normes ISO 14971 et aux exigences Design Control.
• Collaborer avec les équipes interfonctionnelles pour assurer sécurité, efficacité et fabriquabilité.
• Servir de SME en gestion des risques et soutenir les revue de stage et les soumissions réglementaires.
• Identifier, évaluer et atténuer les risques liés au design, à la fabrication et à l’utilisation.
• Conduire des améliorations continues des systèmes de gestion des risques et de qualité.

Skills

Réglementé industrie

Gestion des risques

Conception et design controls

Soumissions réglementaires

ISO 14971

Education

Baccalauréat en ingénierie ou discipline connexe

Job description

## Device Development Assurance ScientistPostuler: Northern Cross, Dublin, Ireland: Temps plein: Offre publiée aujourd'hui: R5673458McDermott Laboratories LimitedViatris est une entreprise mondiale de la santé idéalement placée pour combler la division traditionnelle entre génériques et marques, combinant le meilleur des deux pour répondre de manière plus globale aux besoins de santé à l'échelle mondiale. Avec pour mission d'autonomiser les personnes du monde entier pour vivre en meilleure santé à chaque étape de la vie, nous offrons un accès à grande échelle, fournissant actuellement des médicaments de haute qualité à environ 1 milliard de patients dans le monde chaque année et touchant tous les moments de la vie, de la naissance à la fin de vie, des affections aiguës aux maladies chroniques. Nous avons été inclus dans plusieurs listes de récompenses qui démontrent l'impact que nous avons.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**As a Risk Management Specialist, you will play a critical role in identifying, assessing, and mitigating product risks throughout the development lifecycle, ensuring compliance with international standards and regulatory requirements while supporting successful product delivery and regulatory submissions.Every day, we rise to the challenge to make a difference and here’s how the **Device Development Assurance Scientist** role will make an impact:* Lead and support Risk Management activities throughout the product development lifecycle for medical devices and combination products.* Develop and maintain Risk Management documentation in compliance with ISO 14971, Design Control requirements, and global regulatory standards.* Partner with cross-functional teams including Device Development, Clinical, Pharmacovigilance, Quality, and Regulatory Affairs to ensure products are safe, effective, and manufacturable.* Act as the Risk Management Subject Matter Expert (SME), providing guidance throughout design and development activities, stage-gate reviews, and regulatory submissions.* Identify, assess, mitigate, and communicate product risks related to design, manufacturing, usability, and clinical use.* Monitor and evaluate risk-related data from design outputs, usability studies, and post-market feedback to inform product development decisions.* Support change control assessments and ensure risk management considerations are incorporated into development and quality processes.* Drive continuous improvement initiatives across Risk Management and Quality Management Systems.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.* Experience in a regulated industry (Medical Devices, Combination Products, Pharmaceuticals, Biotechnology, or Healthcare).* Experience applying risk management principles within product development.* Knowledge of Design Controls, Quality Management Systems (QMS), and medical device/combination product regulatory requirements.* Experience supporting regulatory submissions and combination product development would be an advantage.* Knowledge of ISO 14971 and IEC 62366 would be an advantage.* Relevant certification in Lean, Six Sigma, Quality Engineering, or Project Management would be an advantageAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibilityChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.