Biocompatability Specialist - Home based
Vado Med Tech are retained as the exclusive partner for a multi-award-winning Consultancy that employs over 800 staff worldwide with a culture focused on excellence, continuous improvement and collaboration. They have a unique position in the Consulting space with physical laboratory services, clinical research teams in addition to Consulting services bringing devices to market across the world.
They have an unrivalled presence in the medical device, human tissue and IVD space and have already made substantial investments in the European and US infrastructure to support and facilitate this growth.
Due to continued expansion and customer demand they are appointing an additional Biocompatibility Specialist to their existing Biological Safety team of around 10 who work remotely across Europe in either the UK, France or Germany. They have an unrivalled presence in the medical device, human tissue and IVD space and have already made substantial investments in the European infrastructure to support and facilitate this growth.
You can expect a huge variety of work in an array of therapeutic areas that will broaden your skills and knowledge. Our client likes to employ staff who have a desire to develop and challenge their abilities. Actively encouraging personal development giving exposure to projects that will require substantial research and collaboration.
As Biocompatibility Specialist you will:
- 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.
- Ensure biocompatibility studies are in compliance with most recent regulatory requirements.
- Performs and summarizes Clinical Evaluations.
- 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 analysis and write clear concise report.
- Performs and summarizes literature searches.
- Facilitate the collection of test data from other entities as they relate to a specific project.
- Evaluates and determines biological relevance of unexpected results.
To be considered for this role you must have experience with writing risk assessments in accordance with ISO10993. You will have full knowledge of the FDA, MDD/MDR and other global medical devices and biologics regulations. Any experience with DABT (American board of toxicology) would be hugely advantageous for this position.
Interviews will be conducted over the coming weeks via WEBEX. You can expect a Consultant from Vado Med Tech to contact you within 48 hours of application.
This role is remote, using online WEBEX and other web tools to interact both internally and externally. You are able to work anywhere within the UK, France, Germany. Fluency in English is essential. It will suit a self starter who is happy to work as a subject matter expert and have virtual interaction with key team members and customers