Medical Device Decontamination SME

Tunnell Government Services•Bethesda, MD

1d•Onsite

About The Position

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices.

Requirements

Bachelor’s degree (BS in a scientific/technical discipline applicable to sterilization/decontamination).
At least 15 years of experience (direct experience in decontamination/sterilization involving medical products).
Must be able to apply knowledge of decontamination/sterilization to the assessment of medical devices.
Must have an advanced understanding of the various techniques and industry best practices involving technologies to include fumigants, radiation, use of heat/steam, disinfectants, and validation approaches, e.g., indicators.
Ability to read and interpret standards, as well as knowledge of validation and testing methods related to sterilization, biocompatibility, shelf life, and performance testing.
Ability to communicate well with others using excellent written and verbal communication skills.
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.

Nice To Haves

An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
Experience with FDA Sterilization/Decontamination Guidance and other US regulatory requirements and consensus standards (ISO, ANSI) for medical devices highly preferred.

Responsibilities

Provide expert consulting services to assist the CDRH with their regulatory responsibilities, possessing specific expertise, experience, and training in the field of decontamination/sterilization, as relevant to medical devices and device related combination products.
Provide regulatory and technical support to CDRH in the review and disposition of submittals from the medical device decontamination/sterilization industry to include review of 510(k) submissions, consultations, Pre-Submission (Q-Sub) engagements, among others.
Use a combination of technical and operational expertise along with extensive review of FDA guidance documents and standard test methods relevant to each product to conduct a review of each submission, with a goal of ensuring that the product is safe and effective.
Participate in meetings and teleconferences, coordinate meetings with internal and external stakeholders related to marketing applications and pre-submissions.
Support ancillary, prioritized activities in support of the agency, such as performing review of Medical Device Reporting (MDR) submittals.
Develop written reviews and correspondence.
Write detailed documents and reports.