JOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.
As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world.
To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.
We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.What You Can ExpectResponsible for project planning, tracking and reporting at Zimmer Biomet with regards to assessment of the biological safety devices.
Conducts toxicological risk assessments based on data derived from extractables and leachables studies, in support for new product development, product life cycle or support of regulatory submissions.
Collaborates in project work with the chemistry lab, and other departments like research, process engineering, manufacturing, quality and regulatory as well as with other Zimmer Biomet sites and external suppliers (list is not exhaustive).
Serves also as a global subject matter expert to R&D, Operations, Marketing, Sales, Clinical Affairs, Regulatory.How You'll Create ImpactConduct Biological Safety Risk Assessments on orthopeadic device in accordance with ISO 10993 and EU MDR considering interpretation by international agencies and regulations such as FDA.Continuous exploration and education in the field of toxicological risk assessment (i.e.
in-silico, readacross, in vitro test method, 3R methodology)Continuous exploration and education in the field of biological endpoint testingResource for toxicological risk assessmentsInternal technical document creation and approvalParticipate in internal and external audits as subject matter expertCreate Technical Reports, specifications, and other mandatory documents for regulatory submissionsBiocompatibility assessment and organization of respective testingReview and preparation of procedures to keep pace with AAMI / ISO standard developmentRepresent the company via presentations to groups of experts, societies, regulatory bodies and at international meetingsSupport the training of internal and external personnelDevelop and generate material for staff training and data presentationsMaintain relevant scientific and medical knowledge by attending conferences, courses and meetingsEducate internal colleagues across departments and divisions in the area of biological evaluations and toxicological topicsPreparation of responses to inquiries from regulatory agency (ex.
FDA, BSI, CFDA, PMDA.)
in a timely and thorough mannerWhat Makes You Stand OutDemonstrates ownership for integrity of own work and the work of the project teamTechnical advisor.
Can serve as a mentor for other group membersDefinition and justification of testing strategies including rationales for omitting of test endpoints and communication of the critical path for the corresponding projectHas an excellent knowledge of industry standards (ANSI, AAMI, ISO, PDA, etc.
)Applied knowledge and understanding of toxicology principles and best practicesYour BackgroundEducation:Minimum educational requirement is a Master degree in relevant scientific disciplines (e.g.
toxicology or Master of Advanced Studies (MAS)).An advanced degree or significant experience in the field of medical devices biocompatibility (application of ISO 10993 series) is preferableAny toxicology specific certifications are a plus (ERT, DABT, country-specific registration)Professional experience:Minimum of 7 years industrial experience, preferably in implantable medical device industry (orthopedic devices preferred) and/or at contract laboratories.Has achieved a seniority level by leading complex projects of high business relevance in the medical device / pharmaceutical industryHas shown outstanding competencies as subject matter expertHas a comprehensive record of external and internal trainings in his area of expertiseHas proven competence in presenting scientific data to expert groups and key opinion leaders in a clear and convincing mannerHas experience in conveying complex scientific topics in a clear and comprehendible fashionHas shown outstanding competencies as subject matter expert in the following areasCurrent global toxicological guidelines (USP, JP, Ph., Eur., etc.
)SO 10993 standardsEU MDR requirementsRisk assessments of manufacturing contact materialsEOE/M/F/Vet/Disability