Sr. Research and Development Specialist

Job Summary The Sr. R&D Specialist will work with internal business partners and product development teams to provide technical support for biocompatibility processes. This position ensures product safety and leads risk mitigation efforts. This role is responsible for the conduct of biological evaluations, develop biocompatibility strategy, and review biocompatibility test protocols/reports. This position plays a critical role in product development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization.Job Description Responsibilities: Support and consult internal business partners related to biocompatibility issues and challenges to resolve. Authors, review, and approve Biocompatibility strategy, test protocols/reports, and Biological risk assessments for regulatory compliance Evaluates and summarizes biocompatibility and general toxicology data to assess the biological risks Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993 and ISO 14971,for submissions to FDA and other regulatory agencies. Maintain and evolve quality system documentation and procedures relevant to toxicological and biological risk assessment Perform biocompatibility gap analysis and write clear concise report Support biocompatibility, extractable/leachable, or in-vivo safety testing required in support of a product claim Compile risk assessments, identify gaps, and propose solutions. Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards Qualifications: Bachelor’s degree in Chemistry, Biology or related science field. At least 4 years of experience in a medical device or pharmaceutical related field. Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes. Knowledge of CE technical files. Experience with risk assessment and root cause analysis. Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists. Experience communicating with internal and external business partners and cross functional teams with various audiences. Experience in project management skills, with ability and proven track record to plan, manage and develop strategic initiatives to successful goal completion. Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills. Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates. Ability to influence and motivate others to drive results in a multi-location and matrixed environment. Position may require travel up to 10% of the time for business purposes (domestic and international) Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $85,280.00 - $123,760.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.