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30 days old

Principal Toxicologist

Medtronic
Jacksonville, FL 32232
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Principal Toxicologist

Location:

Jacksonville, Florida, United States

Requisition #:

20000COV

Post Date:

Aug 24, 2020


.


**Careers that Change Lives**


In this exciting role as a **Principal Toxicologist** you will havethe responsibilityand
authority to provide toxicological oversight in the design, coordination, and
communication of biological evaluations of medical devices and materials for
the purposes of registration in the U.S. and foreign geographies. A profit-driven business mentality with
simultaneous awareness of maintaining quality control and assurance is
required. On a regular basis, this
position must communicate with Research Development, Quality, Project
Management, Regulatory Affairs, Clinical Studies, Marketing, and Business
Development to ensure new product development, product sustainability, and
crisis management activities are efficiently organized and directed to
establish and maintain acceptable patient safety risk-benefit profiles. This position is responsible for implementing
state-of-the-art toxicological approaches within a continuously evolving
biological evaluation program reliant on a risk management paradigm and
providing relevant training to fellow colleagues within/outside of their
department when necessary. This position
will also function as a subject matter expert on behalf of Medtronic during
interactions with the FDA, Notified Bodies, and Contract Research Organizations


The **Restorative Therapies Group** develops life-restoring therapies
and healthcare solutions that span the care continuum; integrating technologies
and applying clinical and economic evidence to increase patient access, improve
efficiency of procedures and deliver successful patient outcomes.


**The Specialty Therapies division** of
RTG offers a broad portfolio that addresses urologic and gastrointestinal
disorders, conditions of the ear,nose, and throat, as well as stroke
products.


**A Day in the Life**


Responsibilities may include the following
and other duties may be assigned.


+ Designatesand manages responsibilities within the scope of inter-departmental projectsinvolving product development, sustainability, and crisis management.


+ Definesbiocompatibility requirements within complex projects and organizes theircompletion through personal efforts and engaging colleagues, as explainedbelow.


+ Providestechnical expertise/guidance to toxicologists, engineers, regulatory affairsspecialists, and other personnel to improve efficiency of producttime-to-market.


+ Communicateswith relevant stakeholders to optimize device design and evaluatebiocompatibility within an acceptable budget and timeline.


+ Developsbiological safety evaluation strategies implementing a tiered risk-basedapproach to establish ISO 10993 compliance in support of new productdevelopment and registration.


+ Coordinatesbiocompatibility testing with Medtronic Core Technologies Group, MedtronicPhysiological Research Laboratory, or Contract Research Organizations, anddocuments biological assessments using sound scientific principles.


+ Plays anintegral role in the Quality Management System to meet quality goals of thebusiness unit.


+ Exhibitspro-active behavior and organizes meetings to maintain high product qualitystandards for all medical devices.


+ Ensures thelifecycle biocompatibility of all medical devices.


+ Plans andmanages the impact assessment of manufacturing, supplier, and material changesto medical devices with patient contacting components to ensure biologicalsafety and product sustainability.


+ Evaluatesthe biological safety impact of device field issues.


+ Managescommunications with departments to address crises, complaints, CAPAs, andHHEs/IIAs stemming from medical device failures/complications occurring in thefield.


+ Remainsup-to-date with changes in technology, standards, and regulatory policypertaining to toxicology/biocompatibility.


+ Informs andeducates colleagues on the business impact of such changes, and devisestime/money-saving strategies to implement new approaches and address newregulations.


+ Functions asa subject matter expert in toxicology/biocompatibility.


+ Providesexpertise to address questions from regulatory bodies during Medtronic facilityaudits (i.e., assist Compliance), and conducts site visit audits of ContractResearch Organizations.


+ Publishesand presents research as a representative of Medtronic.


+ Designs anddrafts manuscripts for publication that support the biocompatibility, labeling,and registration of medical devices.

+ Attends andpresents research at scientific conferences and forums to influence regulatorypolicy in favor of Medtronic.


+ Allactivities must be performed in compliance with the Quality System.

+ Performs dutiesin compliance with environmental, health and safety related site rules,policies or governmental regulations.

+ All otherduties as assigned.

+ Travelrequirement: Less than 10%


**Must Have: Minimum Requirements:**


**To be consideredfor this role, please ensure the minimum requirements are evident on yourresume.**


7+ years of experience with a Bachelors or 5+ years of experience
with an advanced degree conducting toxicological risk assessments, designing
and performing toxicological assays, and/or overseeing biological safety
assessments. Bachelors degree in Toxicology, Biology, Chemistry, or related
science


**Nice to Have**


+ In-depthknowledge of human physiology, biochemistry, and organ systems toxicology.


+ Must understand biological responses toforeign materials in the human body, including absorption, distribution,metabolism, and excretion (toxicokinetics), particle-mediated toxicity, as wellas the foreign body response.


+ Knowledge ofapplicable ASTM, ISO, FDA, and EN standards as well as regulatorypolicies/guidance documents.


+ An in-depth understanding of ISO 10993biocompatibility standards; knowledge of ISO 18652 and 22442 standards.

+ Knowledge of pertinent sections of REACH, theEU MDD/EU MDR, and Proposition 65 (hazardous substances regulations) as well asICH and FDA Guidance Documents (e.g., Threshold of Toxicological Concern andUse of ISO 10993-1).


+ Proficiencyin conducting quantitative risk assessments on chemical characterizationprofiles as a part of biocompatibility evaluations.

+ Knowledge ofthe risk assessment paradigm (i.e., hazard identification, exposure assessment,dose-response assessment, and risk characterization). Self-sufficient in conducting scientific literature searches, extractingtoxicity data, deriving tolerable exposure limits, as well as calculatingmargins-of-safety, hazard quotients, and hazard indices.

+ PhD degree in Toxicologyor related discipline preferred.


+ Expertise inadvanced scientific principles involving risk assessment, biochemicaltoxicology, organ systems toxicology, pharmacology and physiology, cell andmolecular biology, immunotoxicology, reproductive and developmental toxicology,genotoxicity and carcinogenesis, neurotoxicity, pulmonary toxicity,gene-environment interactions, and biostatistics.


+ Extensivepublication and oral presentation record preferred with peer-reviewedpublications and nationally recognized presentations.

+ Strong multitaskingand organizational skills.


+ Proficient atscheduling and coordinating events, delegating and managing teamresponsibilities, prioritizing and executing assignments, establishing andmeeting deadlines, as well as leading and maintaining productivity in a teamenvironment.


+ Strong problemsolving and analytical skills.


+ An independentcreative/critical thinker with strategic planning/foresight and decision makingabilities.


+ Able to apply newscientific technology and approaches.


+ Involved incontinuous education that is incorporated into the work environment. Willing tocontinuously improve processes for assessing the biocompatibility of medicaldevices.


+ Excellent writtencommunication and oral presentation skills.


+ Exhibits anoutgoing character and ability to tailor communication to specific audiences bymaking complex ideas and projects understandable while maintaining a connectionto the big picture.


+ Able to functionindependently as well as in a team environment.


+ Functions as aninfluential team member capable of motivating others in a cross-functional teamenvironment to achieve project goals.Teaches and educates colleagues to improve their skill set andproductivity within a corporate setting.


+ Computerproficiency with product lifecycle management, word processing, spreadsheet,and analytical software is required.


+ Product lifecyclemanagement software (Arena PLM, Agile PLM, SAP PLM, etc.)

+ Microsoft Office(Word, Excel, PowerPoint, Outlook, Visio, etc.)

+ Graphing andstatistical analysis programs (GraphPad Prism, etc.)

+ Quantitativestructure activity-relationship models (DEREK, OECD Toolbox, ToxTree, etc.)

+ Metaboliteprediction programs (Meteor Nexus, Metaprint2D-React, etc.)

+ Physiologically-BasedPharmacokinetic (PBPK) models


**AboutMedtronic**


Together, we can change healthcare worldwide. At
Medtronic, we push the limits of what technology, therapies and services can do
to help alleviate pain, restore health and extend life. We challenge
ourselves and each other to make tomorrow better than yesterday. It is what
makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to
create meaningful innovations - but we will only succeed with the right people
on our team. Lets work together to address universal healthcare needs and
improve patients lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the
Responsibilities section of this job description are representative of those
that must be met by an employee to successfully perform the essential functions
of this job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. For Office Roles: While
performing the duties of this job, the employee is regularly required to be
independently mobile. The employee is also required to interact with a
computer, and communicate with peers and co-workers. Contact your manager or
local HR to understand the Work Conditions and Physical requirements that may
be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-08-27 Expires: 2020-10-04
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Principal Toxicologist

Medtronic
Jacksonville, FL 32232

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