Principal Toxicologist MedTEST

JOB SUMMARY

• The Biocompatibility Scientist functions as a key team member by energetically supporting the goals ofMedTESTToxicology & Biocompatibility. The Scientist collaborates with associates of diverse technical backgrounds and efficiently executes the biological safety evaluation of medical device (MD) products as per internal procedures and global standards and regulations. This personis responsible forplanning and execution ofin vitroandin vivobiocompatibility evaluations and ensures that products meet the requirements of biological safety according to relevant standards and regulations.

DUTIES & RESPONSIBILITIES

In accordance withall applicable federalstateand local laws/regulations and CorporateDePuy Synthes procedures and guidelines this position:

• Evaluates DePuy Synthes medical device products and materials for biological safety per international medical device regulations and standards GLP (Good Laboratory Practice) guidelines and internal procedures.

• Designs initiates coordinates and interprets laboratory investigations for biocompatibility and toxicology studies for MD materials and products.

• Applies technicalexpertiseto solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.

• Liaises with internal and cross-functional team members to review existing product documentation and coordinates together with more senior staff biocompatibility test strategies to ensureappropriate planningand execution of required testing and completion of relevant deliverables.

• Reviews interprets and summarizes testing data and ensuresappropriate documentationand coordination of central documentation proceduresfor riskassessmentreport completion.

• Interacts closely with and provides technical guidance andexpertiseto internal stakeholders (e.g. R&D Clinical Affairs Regulatory Affairs Manufacturing Quality Engineering and Supplier Management)

• Can support regulatory/notified body requests as part of Audits and File/Product submissions/Reviews in applicable markets.

• Maintains effective communication of business-related issues or opportunities tonextmanagement levelandif necessary SMEs via proper communication methods and/or tools.

• Identifiesand evaluates potential risks and drives resolution with team members peers PMO and management.

• Participates in continuous improvement activities and activelyparticipatesin shaping processes and procedures

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• Bachelors or mastersdegree in biology chemistry toxicology microbiology biomedical engineering or a related scientific discipline with a minimum of 2 years of industrial experience in biocompatibility evaluation or PhD with at least 1 year of industrial experience in biocompatibility evaluation

• Aminimum1-2 years of experience in biocompatibility assessment and evaluation in a medical device pharmaceutical and/or consumer product company or similar combination of professional training and multi-year experience in the industry.

• Experience working in a regulated environment of medical device safety and supporting product submission and audit is; support for worldwide market registration is preferred.

• Knowledge of toxicology & biocompatibility assessment of medical devices coordination and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements

• Understandingofmanufacturing processes of medical devices is preferred.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS

• Abilityto work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is.

• Demonstrates behavior qualities including confidence transparency integrity innovation passion patience and tenacity.

• Excellent written and verbal communication skills. Depending on location local language skills are preferrable.

• Interacts appropriately with all internal and cross-functional partners anddemonstrateseffective use of conflict resolution skills.

• Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are.

• Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.

ADDITIONAL POSITION REQUIREMENTS

• Mayparticipatein organization programs/initiatives outside direct area of responsibility

LOCATION & TRAVEL REQUIREMENTS

• Travel up to 10%

EXTERNAL INTERACTIONS

• Supports regulatory/notified body requests as part of Audits and File/Product submissions/Reviews in applicable markets.Directly interacts with Notified Body (TUV BSI) and Regulatory Agencies representatives