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17 days old

Toxicologist - Medical Devices

Kelly Services
Myrtle Point, OR 97458
Kelly is looking for a **Toxicologist** to manage the Key MDR program from concept through execution. The Toxicologist will be responsible for evaluation of medical device product and combination products for safety as per US and internal procedures and as per the ISO 10993 Standard series. This person will be a contributor to strategy documents, initiation of material characterization studies, in vitro and in vivo study design and final toxicological and biocompatibility reports where necessary to support medical device products for registration. This person is responsible for evaluation of gaps in both testing and safety supporting information and traceability of product testing to existing product on the market. The primary role is to establish toxicological safety assessments for materials, chemical and product constituents the ensure materials safety for pre-marketed and marketed medical device products.




**POSITION DUTIES & RESPONSIBILITIES:**




+ Evaluation of material and product safety for medical devices as per ISO 10993 and FDA requirements.

+ Ensuring appropriate documentation is established & maintained

+ Ensuring that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health) & GLP (Good Laboratory Practice) law

+ Overseeing, designing, implementing, & analyzing testing systems, procedures & test results for biocompatibility / toxicology evaluation for all materials & products

+ Supporting & coordinating activities (study coordinator) related to initiation & generation of study proposals supporting material biocompatibility testing for regulatory submissions

+ Summarizing & interpreting raw data from reports & supports coordination of central documentation procedures required for reports

+ Applying technical expertise to solve biocompatibility / toxicological questions, utilizing ingenuity, experience and independent judgment

+ Interacting closely and providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D & Supplier Management as well as technical guidance.

+ Maintaining a collaborative spirit of the work environment that is both professional and ensures the integrity of others as partners and team members




**EDUCATION & EXPERIENCE REQUIREMENTS:**




+ Minimum of a Doctoral degree (e.g. PhD, ParmD, MD or equivalent degree) in toxicology, biology or a related scientific field is required

+ Board Certification in ATS, DABT, DACVP, or related certification is preferred but not required

+ A minimum of 5 years of experience in toxicology in a medical device is preferred may consider pharma but that would not be ideal

+ Track record of performing scientific toxicological safety assessments for medical device, consumer products or pharmaceuticals is required

+ Experience leading safety evaluation for multiple projects, managing priorities and time management is required

+ Working within the medical device product development is preferred



**Knowledge of:**




+ Toxicology & biocompatibility risk assessment for medical devices

+ Conduct & interpretation of in vivo and in vitro studies

+ Quality procedures

+ ISO, GLPS & FDA-CDRH guidelines as related to biocompatibility testing

+ Word processing, project planning, presentation, e-mail & spreadsheet software



**_THIS POSITION COMES WITH ENHANCED BENEFITS WHICH INCLUDE:_**



50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)



Paid sick days and vacation days



*benefits to be received upon meeting eligibility requirements



**_Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume._**




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-10-09 Expires: 2020-11-09

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Toxicologist - Medical Devices

Kelly Services
Myrtle Point, OR 97458

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