Job Description Summary

This position supports programs to address biocompatibility and nonclinical safety of medical devices and other relevant products produced by Becton Dickinson intended for registration and market by contributing to the development of evaluation programs and preparing and 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.  Contribute to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation programs according to relevant regulatory requirements; including review of literature and assessment of compliance.  Collaborate with CPDT SMEs, 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.  Provide information relevant to testing to CPDT Project Management including device characteristics, clinical use and project/team milestones, as appropriate. 

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

4.  Support and provide biocompatibility-related process training as needed.

5.  Maintain historical databases and perform searches of historical data, as needed.

6.  Maintain knowledge of medical device regulations to assure compliance and conformance of BD CPDT programs for evaluation of medical device and other products.

Bachelor’s degree in toxicology or a closely related field required, and 2 to 6 years of pre-clinical medical device development experience OR Master’s degree in toxicology or a closely related field and 1 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 but also be able to function independently.  Must have excellent scientific written and verbal communication skills. 

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Primary Work Location

USA NC - Research Triangle Park

Additional Locations

USA IL - Vernon Hills, USA NJ - Franklin Lakes, USA UT - Salt Lake City

Work Shift