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 supports an environment of continuous improvement and quality, aligned with BD core values and strategic objectives.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Responsibilities:

1.  Oversee operational activities, including review and processing of change control submissions/change documentation.  Approve 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.  Manages a team of scientists and provides direction and leadership to this team on a wide range of efforts including product development, sustaining engineering support and MDR remediation.  Establishes priorities based on business key goals.

4.  Manage projects as assigned, including coordination of laboratory and sponsor activities.  Provide information relevant to testing to Corporate Preclinical Development/Toxicology (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).

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

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

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

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

Position Requirements:

• Bachelor’s degree in toxicology or a closely related field required, and a minimum of 12 years of pre-clinical experience OR Master’s degree in toxicology and a minimum of 10 years pre-clinical experience OR Ph.D. and a minimum of 5 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 and/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. 

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN

Primary Work Location

USA NC - Research Triangle Park

Additional Locations

USA NJ - Franklin Lakes, USA UT - Salt Lake City

Work Shift

NA (United States of America)