At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
R&D Product DevelopmentJob Sub Function:
Materials/Biomaterials ScienceJob Category:
Scientific/TechnologyAll Job Posting Locations:
Danvers Massachusetts United States of America Houston Texas United States of AmericaJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at is a remote role available in Danvers/Houston within the US. While specific cities are listed in the Locations section for reference please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
#LI-Remote
An internal pre-identified candidate for consideration has been identified. However all applications will be considered.
We are searching for the best talent for Biocompatibility Scientist to be in Danvers MA.
Position Overview
We are seeking a Biocompatibility and Toxicology Subject Matter Expert (SME) to join our team. This role involves leading complex biocompatibility and toxicology projects providing expert scientific assessments and ensuring compliance with international standards such as ISO 10993. The ideal candidate will serve as a key technical resource across functions. This position offers an opportunity to influence product safety regulatory strategy and organizational excellence.
Conduct biocompatibility and toxicology evaluations in compliance with ISO 10993 standards and global regulatory requirements (FDA EU MDR China Japan etc.).
Lead impact assessments of manufacturing supplier and material changes related to product biocompatibility and safety.
Collaborate with internal teams including R&D Regulatory Affairs Quality and external laboratories or CROs to plan execute and interpret biocompatibility testing including chemical characterization studies.
Develop and maintain biological evaluation plans (BEP) and biological evaluation reports (BER) to support regulatory activities.
Coordinate and review biocompatibility testing performed by external laboratories ensuring timely completion and accurate interpretation.
Draft and defend biocompatibility sections of regulatory submissions and technical documentation.
Maintain detailed records of biocompatibility data studies and assessments in accordance with internal SOPs and international regulations.
Support internal SOP development and continuous improvement activities related to biocompatibility and toxicology.
Engage with external standards organizations participate in industry groups and stay current on evolving biocompatibility requirements.
Bachelors degree in biomedical engineering biology biochemistry toxicology analytical chemistry materials science or related field required. Masters degree or higher preferred.
5 years (for Bachelors degree holders) of experience in biocompatibility assessment of medical devices.
Extensive knowledge of ISO 10993 standards with proven experience applying these standards in a regulated environment.
Experience with global regulations including FDA EU MDR REACH and other international requirements.
Strong project management skills with the ability to lead cross-functional teams and external partners.
Excellent verbal and written communication skills.
Familiarity with statistical analysis and Microsoft Office suite.
Board Certified Toxicologist (DBTA) or equivalent qualification.
Experience supporting product stewardship or environmental compliance activities.
Knowledge of biocompatibility and toxicology considerations in product development and lifecycle management.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center() or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
The anticipated base pay range for this position is $115000 to $197000 annuallyAdditional Description for Pay Transparency:
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: o Vacation up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year o Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.