Serve as Subject Matter Expert for internal business partners and product development teams by providing technical expertise for toxicological and biocompatibility processes. This position is responsible for the biological evaluation of medical device, OTC, and cosmetic products, including the conduct of toxicological risk assessments in support of new product development and sustaining activities, as well as in support of global regulatory submissions. This position ensures product safety and leads risk mitigation efforts and is responsible for the conduct of biological evaluations, chemical characterization, and toxicological risk assessments. 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.
Responsibilities:
Support and consult internal business partners with a good technical biocompatibility and toxicological background, with an understanding of relevant compliance standards to resolve issues and challenges.
Author toxicological and/or biological assessments (Biocompatibility) for medical devices and/or cosmetic OTC products with regard to product design, design changes, manufacturing processes and post-production life-cycle activities for regulatory compliance.
Prepares Biological evaluation plans and reports, in compliance with ISO 10993 and ISO 14971, for submissions to FDA, EU MDR, and other regulatory agencies.
Remain current and apply the understanding of ISO 10993, ISO 14971, and regulatory agency guidance documents (e.g. FDA, EU MDR, PMDA, etc.) and pertinent quality system requirements.
Develop and/or propose a regulatory strategy to support Biological evaluation plans to meet the project timeline and budget without jeopardizing the product safety.
Write and/or review experimental protocols, test data, test reports, and overall assessment.
Coordinate biocompatibility, extractable/leachable, or in-vivo safety testing required in support of a product claim
Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.
Qualifications:
Bachelor's degree in Chemistry, Biochemistry, Biology, toxicology, or related science field. Work Experience
10 years industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility and toxicology.
Knowledge of FDA requirements and experience with FDA interactions as part of the 510k approval processes
Knowledge of CE technical files
Working knowledge of FDA and EU MDR and other global medical device regulations and/or biologics regulations, ISO 10993, and 14971.
Preferred Qualifications:
Experience and Knowledge of ISO 18562.
Experience in chemical characterization risk assessment (10993-18). Experience and knowledge of pharmaceutical related field.
Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.).
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.
Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site.
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.
Ability to manage multiple projects in cross functional teams.
Comfortable in a dynamic environment and able to work independently as well as on teams.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page. can the underlined be a link to https://www.medline.com/about-us/inclusion-and-diversity/
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
