Job Description Summary

This position manages programs as the business level SME to address biocompatibility and nonclinical safety of medical devices, pharmaceutical products, and other relevant products produced by Becton Dickinson intended for registration and market by contributing to the development of toxicological evaluation strategies and programs and preparing/reviewing required documentation. The position will primarily support products in the BD Medical Segment, but may support other products and projects as required. A particular focus of the position is support of gap assessment related to European Union Medical Device Regulation (MDR).

Job Description

1.  A as a Subject Matter Expert (SME), leads the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance.  Collaborate with BD project teams, business unit regulatory affairs staff, R&D staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide CPDT deliverables.

2.  Participate on Project Core Teams as an 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.

3.  Lead the authoring and/or review of documents as required for regulatory registration/submission, regulatory compliance and support of product marketing.  Lead MDR gap assessment and document preparation, including Biological Evaluation Reports (BERs).  Also author/review documents for internal change control processes in coordination with CPDT management as needed.

4.  Maintains historical databases and performs searches of historical data, as needed.

5.  Maintain knowledge as an SME of medical device regulations to assure compliance and conformance of BD CPDT programs for evaluation of medical device and other products.

6.  Engage in Standards review relevant to biocompatibility through participation in various global committees that develop standards as appropriate.

Bachelor’s degree in toxicology or a closely related field required, and 6 to 8 years of pre-clinical medical device development experience OR Master’s degree in toxicology or a closely related field and 4 to 5 years pre-clinical medical device development experience OR PhD Degree in toxicology or a closely related field and 2 to 3 years pre-clinical medical device development experience.  

A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (i.e., ISO 10993 and related guidances).  Experience in a United States or EU medical device setting preferred.  Ability to communicate and work effectively with national and international, internal and external teams.  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 while functioning independently as an SME.  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