This position manages programs as the business level Subject Matter Expert to address biocompatibility and nonclinical safety of medical devices, pharmaceutical products, and other relevant products produced by BD intended for registration and market by contributing to the development of toxicological evaluation strategies and programs and preparing/reviewing required documentation. The position primarily supports products in the MDS-IPD and MMS Business but may support other products and projects as required.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities:
Participating in New Product Development projects team/Innovation and sustaining projects meetings as an SME, providing biocompatibility and other CPDT related inputs.
Review and processing of change control submissions/change documentation.
Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices within BD.
Author, Review and/or approve Biological Evaluation Plans and Biological Evaluation Reports/ Toxicological Risk Assessments to support regulatory filings such as 510(k), EU MDR and global submissions for BD products.
May lead a small team of scientists supporting project teams.
Participation in AAMI ISO 10993 Standards Committees and other Industry consortia to represent CPDT Tox and provide inputs on behalf of BD.
Managing Medical Device Regulations and Standards gap assessment for BD products.
Work with the counterparts at CPDT to harmonize and improve the risk assessment documentation for BD product portfolio.
Required Skills/Experience:
Requires a minimum of a Bachelor’s degree with 10 years of relevant experience; Master’s Degree with minimum of 8 years relevant experience; OR Ph.D. with minimum of 6 years relevant experience in Toxicology or closely related field.
A broad background in biology/biocompatibility, toxicology and chemistry including familiarity with recent methodologies and evaluation techniques (ISO 10993).
Experience in conducting toxicological risk assessments in accordance with ISO 10993.
Experience in an FDA regulated medical device setting required.
Ability to communicate and work effectively across a wide national and international, internal and external client base.
Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
Must have excellent scientific written and verbal communication skills.
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.
Preferred Skills/Experience
Board certification in toxicology strongly preferred (e.g., DABT, ERT)
Experience in a GLP preclinical environment preferred.
Fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
Required Skills
Optional Skills
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Primary Work LocationUSA CA - San Diego Bldg A&BAdditional LocationsWork ShiftAt BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$155,900.00 - $257,300.00 USD Annual