Biology Jobs .com Life Science career site  

Analytical Scientist

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

Job Description:


* 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.


* 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.


* Masters (preferred); Doctorate (advantage)


10 %

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Contact Information

Apply for this Job

Please help us spread the word about by telling any organization you know that hires employees with a background in biology that they can advertise their open positions online at for only $1 per day with unlimited job postings and resume database access plus their organization's profile and logo featured online. You can't beat the affordable advertising rates of Biology Jobs .com combined with the highly tartgeted traffic that your job postings will recieve compared to other online job board services.

Whether you are working on your degree, or your have completed your B.A. (bachelor of arts) B.S. ( bachelor of science ) M.S.( master of science ), M.A. ( master of arts ),or Ph.D ( doctorate of philosophy ) degree , and you are looking for a postdoctoral ( postdoc ) job, Biology Jobs .com has job openings posted online at various times for all levels of Biology Jobs from volunteer positions to postdoctoral research jobs to tenured professors, positions with top biotechnology companies and everything in between.