Primary Toxicologist - MedTech Surgery, Inc.
About The Position
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. We are searching for the best talent for a Primary Toxicologist. This role will work a Flex/Hybrid schedule with 3 days per week on-site & must be based within a commutable distance of Cincinnati, OH. Relocation assistance is available to qualified candidates. The Primary Toxicologist will make vital contributions to Front End Innovation, New Product Development, and Life Cycle Management. They are responsible for working with project teams and cross-functional partners on material-centric aspects of our products to ensure patient safety, regulatory compliance, and manufacturing consistency.
Requirements
- Minimum of a Master’s degree in Biology, Chemistry, Biomedical Engineering, or a closely related scientific field required.
- At least of 1-3+ years of professional experience in biocompatibility assessment and evaluation in medical device, pharmaceutical, and/or consumer products required.
- Ability to work collaboratively as a team member across various functions in a challenging and changing environment.
- Experience working in a regulated environment of medical device safety and supporting product submission and audit.
- Proven experience with project management skills, leading safety evaluation for multiple projects, managing priorities and time management.
- Skilled verbal and written communication of issues and technical concepts in a clear, concise manner.
- Proactive, self-motivated performer in an unsupervised environment.
- Proficient use of the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
- Requires up to 10% travel, domestic and international travel.
Nice To Haves
- Ph.D. in toxicology or closely related scientific field strongly preferred.
- Experience supporting product registration is multiple global markets preferred.
- Strong knowledge of biocompatibility assessment methods for medical devices and previous knowledge of how to conduct and assist in the interpretation of in vitro, ex vivo, and in vivo studies preferred.
- Familiarity with medical device product development and design controls preferred
Responsibilities
- Evaluating medical device products for safety in compliance with internal procedures, US and international regulations, and ISO 10993.
- Serving as the sponsor for applicable GLP and non-GLP studies, ensuring the studies are of high quality, completed on time, and comply with regulations and procedures.
- Assisting in the design and implementation of biocompatibility evaluations, toxicology risk assessments, and procedures for Ethicon and across Johnson & Johnson MedTech.
- Reviewing, interpreting, and summarizing toxicological and material chemistry raw data from reports.
- Applying technical expertise to solve complex biocompatibility problems, utilizing ingenuity and business experience.
- Ensuring appropriate documentation is established and maintained to support that the biocompatibility and toxicity testing meets all US and international test requirements per ISO, FDA (US Food and Drug Administration), and GLP (Good Laboratory Practices) regulations.
- Collaborating closely and providing consultative technical expertise to cross-functional partners, including Research & Development, Clinical Affairs, Regulatory Affairs, Surgical R&D, and Supplier Management.
Benefits
- employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
