EUDAMED Technical Expert
il y a 1 jour
We are seeking a highly skilled EUDAMED Technical Expert to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR).
This position requires expertise in data preparation, data validation to regulatory expectations, and uploading processes, along with a solid understanding of regulatory requirements.
Key Responsibilities:- Collect, organize, and format data to meet EUDAMED requirements.
- Ensure data integrity and accuracy by validating entries against regulatory standards.
- Work with internal client teams to address missing or incomplete data.
- Execute mass uploads of device data into the EUDAMED system using XML or other required formats.
- Identify and troubleshoot errors during the upload process, providing timely resolutions.
- Monitor upload progress and maintain records of submissions and confirmations.
- Stay up-to-date on EUDAMED requirements and MDR/IVDR regulations.
- Ensure that all uploads and associated processes align with the latest EU medical device regulations.
- Assist in preparing documentation and reports for audit or regulatory review.
- Collaborate with regulatory, quality assurance, and IT teams to streamline data processes.
- Provide guidance and training to team members on EUDAMED-related tasks as needed.
- Act as a liaison between the client organization and external stakeholders for EUDAMED queries.
- Recommend improvements to data management and submission workflows.
- Develop templates, tools, and best practices to enhance the mass upload process.
The ideal candidate will have a Bachelor's degree in regulatory affairs, life sciences, or a related field. Fluency in French and English is also essential. Prior experience with EUDAMED, including data preparation and mass upload processes, is necessary. Familiarity with MDR/IVDR regulations and their application in medical device submissions is also required. Proficiency in data management tools, including Excel and database systems, is a plus.
This consultancy role offers a competitive daily rate and is open to independent consultants with a registered business. The primary work arrangement is remote with occasional business travel to client sites. Expenses will be paid upon pre-approval by the client.
At Vision Achievement, we strive to deliver exceptional results in a fast-paced environment. If you're an expert in navigating EUDAMED's complexities and possess a passion for ensuring technical compliance, we encourage you to apply.
-
EUDAMED Technical Specialist Expert
il y a 3 jours
Paris, Île-de-France Vision Achievement Temps pleinVision AchievementCompany Overview:We are a forward-thinking organization dedicated to delivering exceptional solutions in the medical device industry. Our mission is to provide unparalleled expertise and support to our clients, ensuring seamless compliance with European Union regulations.About the Role:We seek a highly skilled EUDAMED Technical Specialist...
-
Technical Systems Expert
il y a 18 heures
Paris, Île-de-France Fortinet, Inc. Temps pleinJob Description:As a Technical Systems Expert with Fortinet, Inc., you will play a crucial role in supporting the sales organization in technical matters. This includes pre-sales support, sales calls, and post-sales assistance.Our ideal candidate has experience in technical/pre-sales support as a sales or systems engineer. You should have knowledge of...
-
Senior Technical Expert
il y a 1 mois
Paris, Île-de-France UNIT9 Temps pleinRole OverviewThe Senior Technical Expert at UNIT9 plays a pivotal role in shaping the project's technical direction, collaborating closely with the creative, design, and production teams. This position requires a highly motivated individual with excellent technical skills, including expertise in the UNITY engine, particularly in AR (ARCore and ARKit) or VR...
-
Technical Solutions Expert
il y a 1 jour
Paris, Île-de-France Fortinet, Inc. Temps pleinKey ResponsibilitiesProvide technical expertise in qualifying sales leads from a technical standpoint.Be the main technical resource on sales calls, answering and educating customers on issues ranging from features to integration.Conversant with networking applications and solutions.Lead technical contact for identified accounts, working closely with the...
-
Technical Escalations Expert Lead
il y a 4 semaines
Paris, Île-de-France Datadog Temps pleinDiscover the ideal opportunity to harness your expertise and drive customer satisfaction as a Technical Escalations Expert Lead at Datadog.About the RoleAs a highly skilled professional in multi-channel technical support, you will play a pivotal role in elevating our customers' experience by resolving complex issues and providing exceptional guidance. Your...
-
Fortinet Technical Support Expert
il y a 2 semaines
Paris, Île-de-France Fortinet, Inc. Temps pleinAt Fortinet, we are seeking a highly skilled Techincal Account Manager to join our team. This role is an exciting opportunity for an experienced professional to leverage their technical expertise and customer-facing skills to drive success with key enterprise customers.The successful candidate will possess a deep understanding of data networking protocols,...
-
Technical Account Manager
il y a 3 jours
Paris, Île-de-France Checkout Temps pleinCompany OverviewWe are one of the most exciting fintechs in the world, enabling businesses and their communities to thrive in the digital economy. Our mission is to empower passionate problem-solvers to collaborate, innovate and do their best work.Job DescriptionWe're seeking a Technical Account Manager to join our team. As a key member of our Enterprise TAM...
-
Strategic Technical Solutions Expert
il y a 2 semaines
Paris, Île-de-France Kaminoretail Temps pleinKamino Retail: Enhance Your Career in Retail MediaEstimated Salary: $120,000 - $180,000 per yearAbout the RoleWe are seeking a skilled Technical Account Manager to join our dynamic team at Kamino Retail. As a Technical Account Manager, you will be responsible for providing high-quality technical solutions, building client relationships, and driving...
-
Digital Science Solutions Technical Sales Expert
il y a 2 jours
Paris, Île-de-France Thermo Fisher Scientific Temps pleinAbout the RoleWe are seeking a highly skilled Digital Science Solutions Technical Sales Expert to join our team. As part of Thermo Fisher Scientific, you will play a crucial role in providing technical support to account managers and growing revenue streams.Key ResponsibilitiesAnalyse customer requirements and respond to RFx effectivelyProvide technical...
-
Technical Solutions Expert
il y a 3 heures
Paris, Île-de-France Fortinet, Inc. Temps pleinJob DescriptionWe are seeking an experienced Systems Engineer to join our team in North France. This is a key role that requires strong technical skills, excellent communication abilities, and a passion for delivering exceptional customer service.
-
Senior Technical Field Specialist
il y a 6 jours
Paris, Île-de-France Marshall of Cambridge Holdings Limited Temps pleinMarshall of Cambridge Holdings Limited is seeking a highly skilled Aircraft Support Expert to join its Technical Support Group in Clermont Ferrand, France. This exciting opportunity offers a unique blend of technical expertise and strong communication skills.About the RoleWe are looking for an experienced professional to provide technical support services...
-
Technical Application Support Expert
il y a 3 jours
Paris, Île-de-France Citigroup, Inc. Temps pleinCompany OverviewCiti, the leading global bank, has approximately 200 million customer accounts and conducts business in more than 160 countries and jurisdictions. It provides consumers, corporations, governments, and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking,...
-
Strategic Technical Advisor
il y a 6 jours
Paris, Île-de-France Splunk Inc Temps pleinAbout UsSplunk Inc, a global leader in the unified security and observability platform market, is committed to building a safer and more resilient digital world. Our innovative technology enables customers to keep their digital systems secure and reliable.We're looking for an exceptional business technologist to join our team as a Field CTO & Strategic...
-
Technical Leadership and Development Expert
il y a 2 semaines
Paris, Île-de-France Forest Admin Temps pleinAt Forest Admin, we revolutionize the way businesses manage their back office processes.We offer a cutting-edge solution that allows our clients to focus on their core activities while we take care of the administrative tasks.Salary: $80,000 - $120,000 per year (depending on experience and location).About UsWe were co-founded by Hexa, a renowned startup...
-
Expert Technical Solutions Sales Leader
il y a 2 semaines
Paris, Île-de-France Zendesk, Inc. Temps pleinJob Description:We are seeking a highly skilled Senior Partner Solutions Consultant to join our team in Singapore. As a key member of our sales team, you will play a critical role in driving customer happiness and partner success through technical solutions and competitive aspects.Responsibilities:Collaborate with Partner Managers, Account Executives, Field...
-
Technical Expert
il y a 2 semaines
Paris, Île-de-France Lightspeed Temps pleinOverviewLightspeed is a leading commerce platform that empowers merchants to innovate and deliver exceptional customer experiences. Founded in 2005, we are dual-listed on the New York Stock Exchange (NYSE: LSPD) and Toronto Stock Exchange (TSX: LSPD).SalaryWe offer a competitive salary of approximately €60,000 per year, commensurate with experience.Job...
-
Technical Service Expert
il y a 2 semaines
Paris, Île-de-France SABIC Temps pleinCompany Overview:">SABIC Petrochemical Automotive is a leading player in the global chemical industry, committed to innovation and customer satisfaction. We strive to make a positive impact on the environment and society.">Job Description:">We are seeking an ambitious Technical Service Expert to boost market development activities into the automotive market...
-
Technical Expert for Digital Transformation
il y a 2 semaines
Paris, Île-de-France Audensiel Temps pleinAudensiel is a leading player in digital transformation, business consulting and technology consulting.As a technical expert, you will support clients in all sectors of activity in France and internationally.Digital Transformation: Manage projects using Agile methods, develop applications and ensure acceptance and testing.Consulting: Provide IT consulting...
-
Senior SAP Technical Expert
il y a 2 jours
Paris, Île-de-France Fusion Consulting Temps pleinFusion Consulting is a leading boutique consultancy in the Life Sciences industry, partnering with top pharma, healthcare, and animal health companies worldwide.With over 450 employees and 25 offices globally, our mission is to revolutionize business transformation challenges through innovative solutions. We specialize in S4HANA, Data & Cloud, and...
-
Technical SAP TM Expert for German Market
il y a 2 semaines
Paris, Île-de-France Amm Group Temps pleinAbout the RoleAMM Enterprise GmbH is seeking an experienced Technical SAP Transportation Management (TM) expert to join our team in Germany. This is a challenging opportunity for individuals with strong technical expertise and a passion for delivering high-quality solutions.Key ResponsibilitiesLead the implementation of SAP TM projects, ensuring timely...