Job Description Summary

This position supports programs to address biocompatibility and preclinical safety of all medical devices and other relevant products produced by Becton Dickinson intended for registration and market by preparing, reviewing and submitting various business specific change documentation. Ensures the appropriate regulatory requirements are adequately addressed and documented for the registration of BD products. Oversees projects and programs as assigned, in coordination with sponsors, as well as local Regulatory, Medical Affairs, and CPDT staff. Provides consultation on regulations, methods, policies and practices related to preclinical sciences (biocompatibility, chemistry and toxicology) and safety to address BD interests and issues. A particular focus of the position is support of gap assessment related to European Union Medical Device Regulation (MDR). Provides input and support an environment of continuous improvement and quality, aligned with BD core values and strategic objectives.

Job Description

1.  Oversee operational activities, including review and processing of ACR submissions/change documentation.  Assist and support development of documentation, summaries and interpretation of preclinical evaluations as required for regulatory registration and compliance, and support of product marketing.

2.  A as a Subject Matter Expert (SME), leads the design, execution and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs according to relevant regulatory requirements; including review of literature, and assessment of compliance.  Collaborate with BD project teams, local Regulatory, Medical Affairs, R&D and outside resources as required.

3.  Manage projects as assigned, including coordination of laboratory and sponsor activities.  Provide information relevant to testing to CPDT Project Management including device characteristics, clinical use and project/team milestones, as appropriate.  Manage MDR gap assessment and document preparation, including Biological Evaluation Reports (BERs).

4.  Maintain knowledge of activities in the medical, product and regulatory arenas to assure compliance and conformance of BD CPDT programming for evaluation of medical devices.

5.  Participate on Project Core Teams as a SME, providing Biocompatibility and other CPDT related input as necessary.  Also would coordinate the introduction of other CPDT SMEs to the project team as necessary.

6.  Responsible for conducting risk assessments and reviewing risk assessments conducted by others to assure patent safety and to minimize corporate risk.

Requirements:

Bachelor’s degree in toxicology or a closely related field required, and 8-10 years of pre-clinical experience OR Master’s degree in toxicology and 5-8 years pre-clinical experience  OR Ph.D and 3 years pre-clinical experience. 

A broad background in biology/biocompatibility, toxicology and chemistry including familiarity with recent methodologies and evaluation techniques (ISO 10993).  Experience in an FDA or EU regulated medical device setting required.  Ability to communicate and work effectively across a wide national and international, internal and external client base.  Must be able to multitask and operate effectively within a diverse work environment.  Must be team oriented and have strong interpersonal skills and customer focus.  Must have excellent scientific written and verbal communication skills. 

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Primary Work Location

USA NC - Research Triangle Park

Additional Locations

USA CA - San Diego TC Bldg C&D, USA IL - Vernon Hills, USA NJ - Franklin Lakes, USA RI - Warwick, USA UT - Salt Lake City

Work Shift