Job Description Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. Job Summary Provide scientific support for R&D projects, sales, marketing, and regulatory team by searching, assessing and writing up research related to Biocomposites products. Writing up biocompatibility reports for regulatory submissions. Managing external testing towards regulatory submissions or sales and marketing content. Reports to Pre-Clinical Research Specialist. Location & Working pattern Keele office, standard working hours are Mon-Fri 8.00-16.00 or 9.00-17.00 (35hpw). Duties & Responsibilities Support the Pre-Clinical Research specialist in delivering the preclinical research activities for strategic R&D projects within the company and interactions with regulatory agencies. To support biocompatibility requirements for R&D projects and regulatory approvals for Biocomposites products. To conduct literature reviews on the background material of the device and similar devices. To produce the Biological evaluation plan (BEP) addressing the biocompatibility endpoints identified in ISO 109331. To manage CRO and contract laboratories for required testing. To assist in writing up the results for any required testing and including this in the BEP for the regulatory team to use to write their biological evaluation report (BER). To offer scientific support to other teams within the company (sales, marketing, regulatory). Conduct literature searched to answer questions from clinicians to support sales teams in accordance within compliance requirements. Conduct literature reviews to support sales, marketing and regulatory teams with the scientific basis of the products when required. Essential requirements Level 6 Diploma (level 6 NVQ ordinary degree, degree with honours, degree apprenticeship) in a scientific discipline. Experience with contract research organisations. Knowledge of ISO and FDA regulations for medical devices. Excellent communications skills, scientific writing for different audiences. Desirable requirements Level 7 Diploma (level 7 NVQ, master's degree, postgraduate certificate) in a scientific discipline. Excellent scientific writing and communication skills. Experience working to ISO and FDA regulations for medical devices. Project management experience. Car driver. What do we offer? Competitive salary and benefits! With us, you will receive a competitive salary package and benefits. We grow talent. At Biocomposites we create opportunities to thrive and grow. One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions. Who do we look for? People who are passionate about what we do. People who are open minded to evolving the way we work. People who can work together to transform outcomes and change lives. Benefits: Company events Company pension Employee discount Free or subsidised travel Free parking on-site