Medical Device Decontamination SMEBethesda, MDTunnell Government Services, Inc. is providing professional and scientific services to the FDA Center for Devices and Radiological Health (CDRH) with expert consultants with scientific expertise in the regulation and approval of medical devices.
Responsibilities:
Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise, experience, and training in the field of decontamination/sterilization, as relevant to medical devices and device related combination products. The primary focus of the role is to 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. The candidate will 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
Skills and Qualifications:- The candidate must possess 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 highly preferred.
Candidate must be able to apply knowledge of decontamination/sterilization to the assessment of medical devices. This must entail 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.
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.
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.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
