Biological Safety Specialist

NAMSA; À distance; EUR 45 000 - 60 000; Plein temps

Résumé du poste

Une société leader dans la sécurité des dispositifs médicaux recherche un professionnel pour rejoindre l'équipe des Services de Sécurité Biologique et de Validation. Le candidat idéal doit avoir un diplôme pertinent et une expérience significative, avec des compétences en biocompatibilité et en rédaction de documents. Ce poste se déroule principalement à distance avec des contacts réguliers avec les clients et la conformité aux réglementations en vigueur. Une excellente maîtrise de l'anglais est nécessaire.

Qualifications

• Minimum de 3 ans d'expérience pertinente ou 1 an avec un Master/Doctorat.
• Fluence en anglais et dans la langue locale si nécessaire.
• Connaissance des réglementations pour dispositifs médicaux.

Responsabilités

• Établir et garantir les engagements de calendrier, de budget et de qualité.
• Communiquer activement avec les membres de l'équipe interne.
• Préparer des évaluations de risque et des plans d'évaluation.

Connaissances

Compétences en biocompatibilité

Communication active

Connaissances des normes ISO

Rédaction de documents complexes

Formation

Diplôme de Bachelor ou équivalent

Diplôme de Master ou Doctorat

Outils

Microsoft Word

Description du poste

NAMSA a été la première entreprise indépendante au monde à se concentrer exclusivement sur la sécurité des dispositifs médicaux. NAMSA a commencé à tester les dispositifs médicaux avant que la Food and Drug Administration (FDA) aux États-Unis ne commence à réglementer ces produits en 1976.

Chez NAMSA, 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 vision: inspirer des solutions novatrices pour l’industrie médicale afin de faire 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:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Description du poste:

Who we are :

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support to clients throughout every step of the product development lifecycle and beyond, facilitating market access (e.g. EU, US, China, Japan, and the rest of the world).

Come and work for an organization with the visionto inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the missionto deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core values.

Our values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

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 quality commitments are met for the client.
• Actively communicate with internal team members.
• Understand investigational product(s) and high level understanding of the Medical Device Development Process.
• Handle challenging situations, and know when to call-in help.
• Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Perform project in compliance with regulations.
• Deliver presentations, including preparation, assembling slides, and speaking.
• Provide feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.

• Participate in meetings with prospective clients.
• Provide scope of project and relevant information to support the creation of proposals.
• Offer opportunities to clients for expansion of NAMSA 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.
• Provide technical support to lab staff
• Advise clients on technical issues related to biocompatibility and material characterization
• Develop proposals for Biological Safety projects
• Perform biocompatibility gap analyses and write clear concise reports
• Performs and summarize literature searches
• Evaluates and interprets standard requirements for clients
• Write interpretations of standards, test methodology, annotated bibliographies
• Summarize testing reports for submissions
• Facilitate the collection of test data from other NAMSA entities as they relate to a specific project
• Evaluates and determines biological relevance of unexpected results.

What we are looking :

• This position Requires a minimum of Bachelor’s degree or equivalent experience in a related field, and a minimum of 3 years of relevant experience; or a Master’s or Doctorate degree or equivalent experience in a related field, and a minimum of 1 year of relevant experience.
• Fluency 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 develop biological safety documents and reports that are compliant with applicable standards and regulations.
• Knowledge of and experience with Microsoft Word
• Write and review complex documents