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About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at

We are searching for the best talent for aPrincipal Toxicologist, Toxicology & Biocompatibility, R&D - MedTechto support our medical devices business.This role must be based within a commutable distance of Raritan, NJ(strongly desired), orCincinnati, OH, and will work a Flex/Hybrid schedule with 3 days per week on-site. There is NO remote option.

The Principal Toxicologist, Toxicology & Biocompatibility will serve as a Subject Matter Expert (SME) and a technical lead responsible for Energy, Endomechanical, Biosurgery, Wound Closure & Healing, breast implant Aesthetics & Reconstruction medical devices, and external development opportunities. The role will involve the assessment and evaluation of novel biosorbable materials and technology platforms to deliver innovative surgical technologies and solutions. The Principal Toxicologist efficiently executes the biological safety evaluation of medical device products as per internal procedures and global standards and regulations. This person is responsible for planning and execution of in vitro and in vivo biocompatibility evaluations and ensures that products meet the requirements of biological safety according to relevant standards and regulations.

You will be responsible for:

• Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures.
• Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products.
• Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.
• Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.
• Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.
• Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle.
• Can support regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
• Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools.
• Identifies and evaluates potential risks and drives resolution with team members, peers, and management.
• Participates in continuous improvement activities and actively participates in shaping processes and procedures.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for following all company guidelines related to health, safety, and environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to health, safety, and environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets. Directly interacts with notified body (TUV, BSI) and regulatory representatives
• Performs other duties assigned as needed.
  

Qualifications / Requirements:

• An advanced degree (MS or Ph.D.) in Toxicology or a related scientific discipline is required.
• A minimum of 6 years in relevant industry in medical devices is required.
• A minimum of 8-10 years of experience in toxicology and biocompatibility assessments and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry is required. Experience in medical devices is strongly preferred.
• Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
• Experience in absorbable biomaterials for implantable medical devices, including experience in medical device material degradation and toxicokinetics, is required.
• Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements is required
• Familiarity with relevant industry standards, i.e., ISO 13485, ISO 10993, ISO 14971, and design control systems is required
• Knowledge of laboratory animal care & use practices is strongly preferred
• Understanding of manufacturing processes of medical devices is strongly preferred.

Required and Preferred Skills

• Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required. Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
• Demonstrates technical leadership and mentorship.
• Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
• Excellent written and verbal communication skills. Depending on location, local language skills are preferrable.
• Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
• Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.
• May participate in organization programs/initiatives outside direct area of responsibility
• Travel 6 up to 10%

Subject to the terms of their respective plans, employees are eligible to participate in the Company99s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company99s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation 6120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 648 hours per calendar year; for employees who reside in the State of Washington 656 hours per calendar year
• Holiday pay, including Floating Holidays 613 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave 6 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave 6 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave 6 80 hours in a 52-week rolling period10 days
• Volunteer Leave 6 32 hours per calendar year
• Military Spouse Time-Off 6 80 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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