Biocompatibility Advisor

Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World

As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are an energetic company with a long history of revolutionary products. We devise outstanding solutions that allow patients to lead ordinary lives. We believe the best way to create new value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, establishing last relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference.

To learn more, visit our website: www.vyaire.com

Watch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be

The Impact You’ll Make in this Role

As a(n) Biocompatibility Advisor, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Conduct biocompatibility studies for new and in-process products

• Serve as technical subject matter expert (Interpret data and define qualification strategies for new or modified devices or processes)

• lead biocompatibility studies for new and in-process products including testing (e.g., cytotoxicity, hemolysis, systemic toxicity, intracutaneous reactivity, implantation testing, sensitization testing, VOC testing)

• Collaborate with project teams to establish test recommendations and testing in compliance with biocompatibility guidelines by ISO10993 & ISO18562

• Review and interpret test results for biocompatibility studies

• Develop non-routine protocols, reports, and methods in collaboration with inter-departmental teams

• Write, review, and approve protocols and reports pertaining to biocompatibility

• Provide objective quality assessment through raw data review and data trending

• Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices

• Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.

• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.

• Work with design teams, to create up front initial design requirements to comply with US and OUS agencies Biocompatibility and sterilization requirements.

• Excellent communication skills (written and verbal)

• Knowledge and understanding of standards such as ISO 10993, ISO 18562 ………

• Participate effectively in a team environment.

Your Skills and Expertise

To set you up for success in this role from day one, Vyaire is looking for candidates who have the following required qualifications:

• Minimum Bachelors (relevant field) with a preferred Masters

• Minimum of 1-2 years relevant experience

• Excellent written and verbal communication skills.

• Understanding of ISO 10993

Additional qualifications that could help you succeed even further in this role include :

• Medical Device experience.

• Understanding of ISO 18562 is highly desirable.

• Worked in an FDA / EU regulated environment.

Travel: May include up to [5% domestic/international]

Relocation Assistance: May be authorized

Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees.

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).