Job#: 2055100
Job Description:
Apex Systems is hiring for a Scientistto work remotely. Job details are below!If you are interested, please email an updated copy of your resume to Sr. Professional Recruiter at Apex Systems, Kayla - [email protected]
Job Title: Biocompatibility Chemist/Scientist
Location: 100% Remote
Rate: $45-$52/hour
Contract Duration: 6 months with a strong potential to extend
Job Description:
- Knowledgeable in biocompatibility standards and requirements for marketing medical devices globally (USA, Europe and other countries)
- Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device product
- Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility compliance and appropriate Regulatory and Quality (e.g. MDR) compliance.
- Work closely with supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing test protocols from contract labs
- Collaborate with Biocompatibility team members for alignment with testing strategies
- Coordinate testing through outside laboratories by preparing test samples, submission forms, monitor chemical testing or biological studies, review reports generated by outside laboratories and generate final summary report Author Toxicological Risk Assessment Reports for extractables/leachables, Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510 K Submissions
- Work must show accuracy, attention to detail, completeness of documentation, and be well organized.
- Support interactions with regulatory bodies related to available biocompatibility data for a product
- Support development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
- Appropriately prioritize assignments to meet project schedules
- Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams
Qualifications:
- Bachelors' Degree in Biological Sciences,Toxicology, or Chemistry with courses in Life Sciences
- Understanding of principles, and techniques of toxicology and biocompatibility
- 3-5 years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical device
- Deep working knowledge of ISO 10993 standards for biocompatibility
- Ability to coordinate work through outside service laboratories (e.g. extractables/leachables testing and non-clinical safety studies)
- Experience with sample preparation/extraction/ separation techniques for material analyses
- Experience in polymers, analytical chemistry
- Experience in instrumentation analysis - e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
- Experience interpreting laboratory data and working with mathematical concepts relevant to chemical or biological testing
- Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
- Experience working in Design Control environment; Auditing Skills, Knowledge of quality systems and regulatory submissions
- Strong oral and written communication skills Ability to multitask and track multiple projects at various stages
- Attention to detail; Critical thinking skills to interpret available data and recommend strategies to resolve technical challenges.
- Strong computer and general software skills
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.
