Global Biocompatibility Specialist

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POST DATE 8/16/2016
END DATE 12/19/2016

Karl Storz Charlton, MA

Karl Storz
Charlton, MA
AJE Ref #
Job Classification
Full Time
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Sigma Systems is looking to hire a Global Compatibility Specialist.

* Bachelor's degree in Toxicology, Chemistry, Chemical Engineering, Material Science or Engineering.
* 3-5 years of relevant experience in biocompatibility. Certifications in biocompatibility or toxicology desired.
* ISO 10933 Experience required
* Relevant experience in the regulated environment, either at another medical device company or in a contract laboratory
* Technical background sufficient to understand devices and medical procedures so that adequate justification, description and explanations can be documented to support the FDA and other regulatory bodies in product submissions.
* Knowledge of relevant sections of the Code of Federal Regulations pertaining to medical devices in general and more specifically, biocompatibility regulations / standards and toxicology assessments.
* Ability to read and interpret Regulatory/Legal documents and determine the required compliance activities.
* Excellent technical writing ability, good organizational skills, good computer skills (e.g., MS Office), project management skills, and good communication skills


* Determine regulatory requirements/status for new/proposed products in material biocompatibility and other related areas.
* Determine appropriate level of product pre-clinical safety testing based on international standards and regulatory requirements associated with biocompatibility and toxicology.
* Provide technical expertise and support to the submission team on obtaining marketing clearance for all devices, with regard to biocompatibility certifications.
* Support the creation, approval, and maintenance of biocompatibility and toxicology testing and documentation for medical devices.
* Update and maintain the company's biocompatibility database.
* Communicate with regulatory agencies (including European, US, and Canadian and others) to advance product approvals, submission determinations, etc. as it pertains to biocompatibility and toxicology of medical devices.
* Provide support and guidance within the global organization regarding regulatory compliance as it pertains to biocompatibility and toxicology issues associated with medical devices.
* Participate in supplier qualification audits of external test houses as requested.