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Teleflex

Analytical Scientist

Post Date:Dec 12, 2018Type:Full-Time
Start Date:12/12/2018Salary:
Location:US-NC-Morrisville Job Reference:210_5000407107306
Skills:
 

Job Description:


PRINCIPAL RESPONSIBILITIES:

* 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. * Expert in performing extractable and leachable guidance and risk assessments for medical devices * Support the creation, approval, and maintenance of biocompatibility and toxicology testing and documentation for medical devices. * Communicate with regulatory agencies (including European, US and Canadian and others) to advance product approvals, submission determinations, etc. as it pertains to biocompatibility and material toxicity. * Provide support and guidance within the global organization regarding regulatory compliance as it pertains to biocompatibility and toxicology issues associated with medical devices. * Assists in assuring compliance to Quality Management System Requirements as it relates to biocompatibility and toxicology issues. . * Keep abreast of new and emerging standards and guidance documents with respect to biocompatibility. Must have working knowledge of ISO 10993, ISO 18562, FDA guidance etc.

EDUCATION / EXPERIENCE REQUIREMENTS:

* Bachelor's Degree required, Masters (preferred); Doctorate (advantage) * Minimum of 5 years of experience * Leachable and extractable experience * ISO 10993 experience * Experience in a regulated environment-either in another medical device company or in a contracted lab. * Certifications in biocompatibility or toxicology desired * 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. * Ability to work with the company's global team members and other departments, as well as external customers, vendors, consultants and regulatory authorities. * Excellent technical writing ability, good organizational skills, good computer skills (MS Office), project management skills, and good communication skills.

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

* Masters (preferred); Doctorate (advantage)

TRAVEL REQUIRED:

10 %

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled




Contact Information
Teleflex



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