Présentation du Poste: Project Manager – Medical Devices chez DNV
Contexte Général
DNV, un leader mondial en matière de certification et d’assurance, offre une opportunité de travail significative au sein de son équipe en Corée. En tant que Project Manager pour les dispositifs médicaux, le candidat retenu sera au cœur d’un projet crucial pour garantir la conformité et la qualité des dispositifs médicaux dans le cadre des normes de l’Union Européenne.
Description du Poste
Rôle Principal
Le Project Manager assume une responsabilité globale dans le projet MDR (Medical Device Regulation). Son rôle est de s’assurer que les missions s’exécutent conformément aux accords de certification et aux exigences du système de gestion de la qualité. Il devra également veiller à une communication interne fluide avec toutes les ressources impliquées dans le projet, ainsi qu’avec les clients.
Responsabilités
Les missions du Project Manager incluent, mais ne se limitent pas à :
- Gestion de la Documentation: Veiller à ce que le pack audit soit téléchargé dans le système de production.
- Préparation des recommandations de certification basées sur l’audit du QMS.
- Communication Proactive: Informer les responsables de vente et autres parties prenantes des changements apportés à la proposition ou à l’accord de certification.
- Planification et Coordination: Organiser des sessions de planification pour le développement et l’exécution du projet, en définissant des objectifs clairs et en identifiant les parties prenantes impliquées.
Compétences Clés
Le candidat idéal devra posséder les compétences suivantes :
- Expérience Requise: Minimum de 10 ans dans un rôle similaire, de préférence dans l’industrie médicale.
- Formation: Diplôme universitaire en rapport avec le rôle (qualification technique souhaitée).
- Compétences Linguistiques: Maîtrise de l’anglais indispensable.
- Gestion de Projets Complexes: Historique démontré de gestion de projets complexes impliquant plusieurs parties prenantes.
Conditions de Travail
Environnement de Travail Flexible
DNV propose un horaire de travail flexible avec des possibilités de travail hybride pour favoriser un bon équilibre entre vie professionnelle et personnelle.
Avantages Offerts
Les employés bénéficieront de :
- Congés généreux (congés annuels et spéciaux)
- Polices d’assurance variées (assurance vie d’entreprise, assurances locales, etc.)
- Avantages additionnels (allocations repas et transport, primes de fin d’année, assistance à la scolarité, etc.)
- Un salaire compétitif assorti d’une part bénéficiaire.
Engagement envers la Diversité
DNV est un employeur garantissant l’égalité des chances et s’engage à considérer tous les candidats qualifiés sans discrimination fondée sur le genre, la religion, la race, l’origine nationale ou ethnique, et d’autres critères protégés. Cet engagement à la diversité fait partie intégrante de la culture de l’entreprise.
Conclusion
Le poste de Project Manager – Medical Devices chez DNV en Corée offre une occasion exceptionnelle pour un professionnel expérimenté de contribuer à un secteur essentiel. En joignant DNV, le candidat participe à la transformation de l’industrie en matière de confiance et de transparence, tout en favorisant des résultats durables et responsables.
Date de Publication: 10 juillet 2025
Localisation: Séoul, Corée du Sud
Postulez dès maintenant pour rejoindre une équipe dynamique et engagée!
📅 Date de publication de l’offre : Thu, 10 Jul 2025 06:47:30 GMT
🏢 Entreprise : DNV
📍 Lieu : 서울시
💼 Intitulé du poste : Project Manager – Medical Devices
💶 Rémunération proposée :
📝 Description du poste : Job Category: AuditorJob Description:The Project Manager is a key role in the MDR project. The Project Manager has the overall responsibility to ensure that the project is performed according to the Certification Agreement and the quality management system requirements, ensure a good internal communication with all resources and units involved in the project to have a smooth and efficient execution of the project, and to ensure a good cooperation and communication with the customer.Responsibilities:
- Ensures that the audit package is upload in the Production system.
- Recommend certification based on the QMS audit and prepares recommendation for certification, including the draft certificate (assisted by the assessor for MDR certificate), and sends audit and assessment documentation and reports to technical review.
- Communicates with Planner and/or person in charge of Sales if any changes in Certification Proposal or agreement must be initiated.
- Communicates with Certification Manager, MDSAP Technical Manager for MDSAP Processes, and/or Global Clinical Affairs Manager if issues related to safety and performance of the medical device is identified during the audit/assessment, and the need of suspension/withdrawal of the certificate must be considered.
- Coordinate and lead planning sessions for project development and execution
- Manage staffing and other resources needs to maximize potential for successful execution of projects
- Coordinate within medical services delivery by working closely with the Global Certification Unit(GCU) and other units/managers
- Define project objectives and scope, identifying involvement of internal and external stakeholders
- Conduct risk analysis to reduce unforeseen obstacles and costs
- Create detailed schedule, project parameters, and budget expectations
- Create a complete project plan with timelines from technical file submission to certificate issuance
- Conduct periodic scope, schedule, and cost reviews using industry best practices, to identify needed adjustments
- Measure project performance and progress throughout campaign execution
- Manage client and other stakeholder expectations to maintain productive and engaged relationships
- Ensure professional and responsive customer support, leading to high customer satisfaction and maintaining a strong market reputation
- Document project activities, obstacles, costs, and results
- Assist the planning & scheduling in accurate scheduling and optimal resource utilization
- Delegate project activities and duties in accordance with team members’ strengths and experience
- Provide summarized project plan documentation to departmental managers, clients, and other stakeholders as needed
- Act as single point contact for the customer for all project related activities
- Engage in continual learning to remain abreast of industry best practices, new technologies, and emerging standards
- Collaborate with and lead teams to deliver results on schedule and within budget limits
- Maintain medical services to meet the requirements from Notified Bodies(NB) and accreditation standards
- Cooperate with the finance team for forecast preparation, analysis, and support in invoicing processes
- Assist in handling complaint management to promptly address issues and uphold service quality
- Execute other role duties as assigned
Responsibilities:
- Flexible work schedule with hybrid/selective working opportunities for better work-life balance
- Generous paid leaves (annual paid leave, special paid leave)
- Pension and insurance policies (corporate life insurance, local group insurance, travel insurance, retirement pension)
- Additional benefits (meal allowance, transportation allowance, holiday bonus, tuition assistance for children, annual medical check-up, long service awards)
- Competitive salary along with profit share
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.Qualifications:Required:
- Minimum of 10 years of relevant experience in a similar role, with a preference for experience within the medical industry
- University degree or equivalent qualification; technical background is a plus
- Fluent in English is a must
- Demonstrated experience in managing complex projects involving multiple stakeholders
- Strong client communication skills and proven ability to build and maintain excellent client relationships
- Excellent organizational, coordination, and project management abilities
Preferred:
- Self-motivated with a positive and proactive attitude.
About Us:About SCPAWe help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
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