Sr Biomedical Specialist

41037 Mirandola, Province of Modena, Italy Req #304
Friday, March 1, 2024
Position Title: Sr. Biocompatibility Specialist


A Day in the Life Working as a Biocompatibility Specialist you will be responsible for managing the existing biocompatibility testing or develop new protocols . You will manage projects assigned and works with other stakeholders to achieve desired results. Most of the time you will be focus on drive the collection of proper documentationand design the proper biocompatibility testing to ensure the biomedical equipment is compliant with applicable regulatory requirements and quality control standards.
Responsibility: Define biocompatibility requirements for medical device and pharmaceutical products. Determine testing and evaluation strategies to assess potential biological safety risks for materials contact with the human body. Support chemistry studies to characterize extractable/leachable chemicals. Support toxicological risk assessments of extractable/leachable chemicals, and derivation of allowable limits. Interface with cross-functional teams for product development, and support project execution and prioritization. Partner with internal and external laboratories to perform all the analysis required. Provide the assistance to other team with complex evaluations that require considerable judgment and initiative. Must Have: Master's degree in biomedical engineering, chemistry, biology, pharmacy or similar faculties 3-5 years of relevant biocompatibility working experience Knowledge of the principal analytical techniques needed for biocompatibility characterization (extraction, HPLC-MS, GC-MS, Cytotoxicity) Knowledge and application of standards for biocompatibility of health care products(ISO 10993) Nice to Have: Knowledge of the basic toxicological principle Knowledge of Design Control process for medical device Knowledge of applicable standards for method development and validation(ICH Q2, ICH Q14, USP ; USP ; USP ) Design and Development of new or existing pharmaceutical products formulation in compliance with development pharmaceutical standard (ICH Q8; ICH Q9; ICH Q12) Knowledge of applicable standard for packaging for pharmaceutical use (USP 1661, 661, 662, 663) 41037 Mirandola, Province of Modena, Italy#J-18808-Ljbffr