Experienced Remote Biocompatibility Scientist – Medical Device Industry Expertise in Regulatory Compliance, Toxicology, and Analytical Chemistry

Introduction to Apex Systems

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. We value innovation, collaboration, and continuous learning, offering 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.

Job Overview

We are seeking an experienced Remote Biocompatibility Scientist to join our team. As a Biocompatibility Scientist, you will play a crucial role in ensuring the safety and efficacy of medical devices by assessing their biocompatibility. This is a 100% remote position, offering you the flexibility to work from the comfort of your own home. The contract duration is 6 months, with a strong potential to extend. The hourly rate for this position is $45-$52, depending on your experience and qualifications.

Key Responsibilities

• Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device products
• 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 your supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategies and review 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, monitoring chemical testing or biological studies, reviewing reports generated by outside laboratories, and generating final summary reports
• Author Toxicological Risk Assessment Reports for extractables/leachables, Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510(k) Submissions
• Support interactions with regulatory bodies related to available biocompatibility data for a product
• Support the development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
• Prioritize assignments to meet project schedules and ensure timely completion of Biocompatibility deliverables to project teams

Essential Qualifications

To be successful in this role, you should have:

• A Bachelor's 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 the medical device industry or biocompatibility research organization working on biocompatibility of medical devices
• 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, and 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
• Strong oral and written communication skills, with the ability to multitask and track multiple projects at various stages
• Attention to detail and critical thinking skills to interpret available data and recommend strategies to resolve technical challenges

Preferred Qualifications

While not essential, the following qualifications are desirable:

• Experience working in a Design Control environment
• Auditing skills and knowledge of quality systems and regulatory submissions
• Strong computer and general software skills, with experience in using various software applications to analyze and interpret data

Skills and Competencies

To excel in this role, you should possess:

• Strong analytical and problem-solving skills, with the ability to interpret complex data and develop effective solutions
• Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
• Strong attention to detail and organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously
• Ability to work in a fast-paced environment and adapt to changing priorities and deadlines
• Strong knowledge of regulatory requirements and industry standards, with the ability to apply this knowledge to ensure compliance

Career Growth Opportunities and Learning Benefits

At Apex Systems, we are committed to the growth and development of our employees. As a Remote Biocompatibility Scientist, you will have access to:

• Quality career resources and training programs to enhance your skills and knowledge
• Certifications and development opportunities to advance your career
• A comprehensive benefits package, including health insurance, retirement plans, and paid time off
• Opportunities to work on diverse projects and collaborate with experienced professionals in the industry

Work Environment and Company Culture

At Apex Systems, we value innovation, collaboration, and continuous learning. Our company culture is built on the principles of:

• Respect and inclusivity, with a commitment to diversity and equal opportunities
• Open communication and transparency, with regular feedback and coaching
• Collaboration and teamwork, with a focus on achieving common goals
• Continuous learning and development, with opportunities for growth and advancement

Compensation, Perks, and Benefits

We offer a competitive hourly rate of $45-$52, depending on your experience and qualifications. In addition to your salary, you will also be eligible for:

• A comprehensive benefits package, including health insurance, retirement plans, and paid time off
• Opportunities for career growth and development, with access to training and certification programs
• A flexible and remote work environment, with the ability to work from the comfort of your own home
• Recognition and rewards for outstanding performance, with opportunities for bonuses and incentives

Conclusion

If you are a motivated and experienced Biocompatibility Scientist looking for a new challenge, we encourage you to apply for this exciting opportunity. With a competitive salary, comprehensive benefits package, and opportunities for career growth and development, this is a fantastic chance to advance your career and make a meaningful contribution to the medical device industry. Please submit your application today, including your updated resume and a cover letter outlining your experience and qualifications.

Apply now and join our team of experienced professionals!