Senior Biocompatibility consultant
Our team is growing, and we are looking for a talented senior biocompatibility consultant to join us in working to meet our clients’ needs. Your skills will be part of what GBA Key2Compliance offers our customers. You will be part of our team of both experts and generalists who help innovative companies to CE mark medical devices and IVD products. Together, we can give our clients the most qualified support available.
We are proud that our core value is Patient Safety. Since 1994, we’ve helped companies develop safe products that help people all over the world. Join our team of highly engaged co-workers, in a great atmosphere with every opportunity to grow and develop in the industry.
About the role
As a senior biocompatibility expert you will be part of our team of specialists that work with a wide variety of products within MedTech and IVD, as well as combination products. Apart from working with other members of the Biological Safety team, you will also be able to collaborate with colleagues in the QA/RA, Clinical Development, Pharma, and Education/Training teams. As a senior consultant, you will manage your own projects in dialogue with the client and with support from the team, writing plans and reports for regulatory submissions of products world-wide. You will be supporting medical device manufacturers with developing biological evaluation strategies and also, depending on your experience, in evaluating other aspects of preclinical safety such as sterilization, bioburden, shelf-life, reprocessing, transport and packaging validation, or with assisting IVD clients in designing and documenting the analytical performance evaluation. The Biological Safety team often coordinates biological safety studies or other required tests with appropriate laboratories, or assists in test design as well as review of plans and reports.
If you enjoy teaching, there is a possibility to assist the Training and Courses team with giving courses in e.g. biocompatibility assessment. There is also a possibility to take part in international standardization work.
About you
We believe that you, to be successful in the role, should have several years of experience from the medical device industry with specific focus on biocompatibility assessments, preferably of several different types of products. Documented experience regarding material science, analytical chemistry and/or regulatory toxicology is considered an advantage, as well as practical experience from laboratory work. You should have good writing, communication and presentation skills and an analytical mindset. We expect you to be a team player who likes to share knowledge, and you work in a structured and well-organized manner.
Key duties
You will support our clients with advice in biological evaluations, writing plans and reports, performing GAP analyses towards relevant regulations and standards, communicating with test laboratories to achieve the best possible evaluation of products, and support in communication with notified bodies. There is flexibility in the role depending on your interest and wish for continued professional learning.
Qualifications
Education Requirements/Certifications
• Ph.D. or Master’s degree in relevant field or have through work acquired relevant knowledge
Required Knowledge/Skill
• In-depth knowledge of the ISO 10993 standard series and related standards
• Full professional written and oral communication skills in English and either Swedish or Danish
• Thorough but pragmatic
• Solution oriented
• Positive
• Flexible
Experience Required
• Solid experience of biocompatibility assessment of medical devices
• Experience in material sciences is a bonus
• Experience in analytical chemistry is a bonus
• Experience in regulatory toxicology is a bonus
• Experience in practical laboratory work is a bonus
Information and contact details
Place of employment: Gothenburg, Stockholm, Lund, or Copenhagen
Scope: Full time
Questions: : Please contact Camilla Lohman, camilla.lohman@interactivesearch.se, or the Director of the Biological Safety Team, Kristina Fant, kristina.fant@key2compliance.com
Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.
We look forward to receiving your application!
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