Job Description

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Job Summary

nnZimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Responsible for Research project planning, executing, and reporting with regards to assessment of manufacturing materials and biological safety of devices as well as cleaning specifications, analytical testing development and biological safety assessments. Serves as subject matter expert and scientific advisor to R&D, Operations, Marketing, Sales, Clinical Affairs, Regulatory (list is not exhaustive). Acts as scientific liaison between external key opinion holders and Zimmer Biomet. Collaborates in project work with departments like process engineering, manufacturing, quality and regulatory as well as with other Zimmer Biomet sites, and external suppliers (list is not exhaustive). Supports Complaints investigations and other Biomaterials-related Research projects as required.

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Principal Duties and Responsibilities

nn Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR.
Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO)
Write toxicological assessment and biological evaluation reports
Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner
Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
Proactively identify future biological safety challenges and develop strategies to address them
Review and prepare procedures to keep pace with standards development
Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
Help to develop and generate material for staff training and data presentations
Provides support for key opinion leaders

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions for purposes of the ADA.

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Expected Areas of Competence

nn Has shown outstanding competencies as subject matter expert in the following areas
Current global toxicological guidelines (USP, JP, Ph., Eur., etc.)
ISO 10993 standards
EU MDR requirements
Risk assessments of manufacturing contact materials
Working knowledge of analytical chemistry
Ability to work within a multidisciplinary team setting with good interpersonal skills
Excellent oral and written communication skills
Has a comprehensive record of external and internal training in area of competence
Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.
Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
Handles discussions of complex topics with confidence
Demonstrates ability to discuss sensitive information with and tailor communication style to listeners perspectives, including management, surgeons, and external contacts
Shows leadership skills and initiative

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Education/Experience Requirements

nn Minimum educational requirement is a MS(PhD degree preferred in Toxicology (DABT certification a plus)
Minimum of 10 years industrial experience, preferably in implantable medical device industry(orthopedic devices preferred) and/or at contract laboratories.

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Travel Requirements

nnUp to 20%

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Additional Information

nnEOE/M/W/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

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