Medical Device Decontamination SME

Responsibilities

• Provide expert consulting services to assist the CDRH with their regulatory responsibilities.
• Conduct a review of each submission, ensuring the product is safe and effective.
• Participate in meetings and teleconferences, coordinate meetings with internal and external stakeholders.
• Support ancillary, prioritized activities in support of the agency, such as reviewing Medical Device Reporting (MDR) submittals.
• Develop written reviews and correspondence.
• Write detailed documents and reports.

Qualifications

• A bachelor’s degree (BS in a scientific/technical discipline applicable to sterilization/decontamination).
• An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
• At least 15 years of experience is required (direct experience in decontamination/sterilization involving medical products).
• Experience with FDA Sterilization/Decontamination Guidance and other US regulatory requirements and consensus standards (ISO, ANSI) for medical devices is highly preferred.
• The candidate must be able to apply knowledge of decontamination/sterilization to the assessment of medical devices, including an advanced understanding of various techniques and industry best practices involving technologies such as fumigants, radiation, use of heat/steam, disinfectants, and validation approaches.
• The ability to read and interpret standards, as well as knowledge of validation and testing methods related to sterilization, biocompatibility, shelf life, and performance testing, is critical.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
• Must be a US Citizen or Full Green Card holder.