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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.
Job Responsibility:
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
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
Nice to have:
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