Biological Safety Specialist

This a Full Remote job, the offer is available from: EMEA reputed company a été la première entreprise indépendante au monde à se concentrer exclusivement sur la sécurité des dispositifs médicaux. reputed company a commencé à tester les dispositifs médicaux avant que la Food and Drug Administration (FDA) aux États-reputed company ne reputed company à réglementer ces produits en 1976. Chez reputed company, nous façonnons l’industrie du dispositif médical car notre entreprise a joué un rôle clé dans l’élaboration des méthodes d’essai qui régissent désormais notre activité, activité au sein de laquelle nous sommes devenus leader. De plus, nous accompagnons nos clients à chaque étape du cycle de développement des produits. Venez travailler pour une organisation riche de valeurs : Une reputed company : inspirer des solutions novatrices pour l’industrie médicale afin de reputed company progresser les soins de santé à l’échelle mondiale, d’améliorer la vie des patients et d’accélérer la réussite de nos clients Une mission : fournir les meilleures solutions de développement de l’industrie médicale à l’échelle mondiale grâce à nos équipes, notre expertise et nos technologies Des valeurs :

• Agir avec intégrité dans tout ce que nous faisons
• Offrir la meilleure reputed companyérience à nos clients
• Développer des talents et fournir une expertise
• Réagir avec agilité et offrir des résultats pertinents
• Encourager la collaboration, la diversité des opinions et des idées

reputed company du poste : Who we are : reputed company pioneered the industry and was the first independent company in the world to reputed company solely on medical device materials for safety. reputed company started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. reputed company has been a key contributor to the development of the test reputed company that govern our industry. We have become the industry’s premier provider. We reputed company support to clients throughout every reputed company of the product development lifecycle and reputed company, facilitating market reputed company (e.g. EU, US, China, Japan, and the rest of the world). Come and work for an organization with the reputed company to reputed company innovative MedTech solutions that advance global reputed company, improve patient lives and accelerate reputed company reputed company and the mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core values. Our values:

• reputed company with reputed company in everything we do.
• reputed company best-in-class customer experiences.
• reputed company superior talent and deliver expertise.
• Respond with reputed company and reputed company reputed company results.
• reputed company collaboration, diverse perspectives and reputed company.

Job reputed company: As part of the Biological Safety and Validation Services team, your will be working remotely from one of the countries where we have an entity : Belgium, UK, Germany, Spain or France. Your responsibilities will be the following :

• Establish and ensure schedule, budget and reputed company commitments are met for the reputed company.
• reputed company communicate with internal team members.
• Understand investigational product(s) and high level understanding of the Medical Device Development Process.
• Handle challenging situations, and know reputed company to call-in help.
• reputed company as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• reputed company project in compliance with regulations.
• Deliver presentations, including preparation, assembling slides, and speaking.
• reputed company feedback regarding project team members using the appropriate performance management tools and processes, in a reputed company manner.
• Participate in meetings with prospective clients.
• reputed company scope of project and relevant information to support the creation of proposals.
• Offer opportunities to clients for expansion of reputed company services.
• Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993-1 ISO 10993-17 and ISO 14971, for submissions to FDA and other regulatory agencies
• Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards
• Working knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 series, and 14971
• Ensure biocompatibility studies are in compliance with most recent regulatory requirements.
• reputed company technical support to lab staff
• Advise clients on technical issues reputed company to biocompatibility and material characterization
• reputed company proposals for Biological Safety reputed company
• reputed company biocompatibility gap analyses and write reputed company concise reports
• Performs and summarize literature searches
• Evaluates and interprets reputed company requirements for clients
• Write interpretations of standards, test methodology, annotated bibliographies
• Summarize testing reports for submissions
• Facilitate the collection of test data from other reputed company entities as they relate to a specific project
• Evaluates and determines biological relevance of unexpected results.

reputed company are looking for :

• This position Requires a minimum of Bachelor’s degree or equivalent experience in a reputed company field, and a minimum of 3 years of relevant experience; or a Master’s or Doctorate degree or equivalent experience in a reputed company field, and a minimum of 1 year of relevant experience.
• reputed company in English and local language, if different, required.
• Knowledge and experience with applicable standards and regulations for medical devices
• Ability to assess/audit compliance of biocompatibility and material characterization results to applicable standards and regulations.
• Ability to reputed company biological safety documents and reports that are compliant with applicable standards and regulations.
• Knowledge of and experience with reputed company Word
• Write and review reputed company documents

This offer from "reputed company" has been enriched by reputed company.com and got a 77% reputed company score. Apply tot his job Apply To this Job