Top 4847 Medical device consulting Jobs

Medical Device Decontamination SME
Tunnell Government Services —Washington, DC
- Remote
- Bachelor of Science
- 11+ years
- Bachelor's degree
Quick Apply
Program Manager, Medical & Scientific Affairs (IVD, Medical Device)
Leica Biosystems —Deer Park, IL
- $130,000 - $145,000 a year
- Full-time
- Remote
- Medicine
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
Document Control Specialist - Medical Device #2902
Enhanced Compliance Inc. —Burlingame, CA
- Full-time
- Microsoft Word
- US work authorization
- Senior level
Senior Research Scientist, Medical Device Security Analysis
Harbor Labs —Baltimore, MD
- Full-time
- Computer Science
- HIPAA
- Research
Associate Director/Director - Analytics Consulting - Medical Device
Tiger Analytics Inc. —Jersey City, NJ
- Full-time
- Remote
- 11+ years
- SQL
- Mentoring
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Consulting Scientist
Waters Corporation —Milford, MA
- $146,500 - $244,000 a year
- Full-time
- 11+ years
- Doctor of Philosophy
- Mentoring
Medical Spa & Wellness Clinic Partnerships Executive
Xenios —Remote
- $40,000 - $100,000 a year
- Contract
- Remote
- Mid-level
- Commercial
- Flexible schedule
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6d
Quality Engineer II - Medical Device #0959
Enhanced Compliance Inc. —Saint Paul, MN
- Full-time
- Engineering
- Mid-level
- 3 years
Patent Analyst - BIOMEDICAL/MEDICAL DEVICES
Global Patent Solutions —Chandler, AZ
- Full-time
- Remote
- Computer literacy
- Bachelor of Science
- Bachelor's degree
Associate Consultant
BGBx Consulting —Washington, DC
- $90,000 a year
- Hybrid work
- Microsoft Word
- Bachelor of Science
- Office
- Paid holidays
- Health insurance
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PCT Patent Analyst (Contract) - Mechanical/Medical Devices
Clarivate —Ann Arbor, MI
- Part-time
- Remote
- Background check
- Mid-level
- Master's degree
Product Owner
Topflight Apps —Remote
- $77,500 - $93,600 a year
- Part-time
- Remote
- Mid-level
- 2 years
- Flexible schedule
Implementation Consultant I - US Remote
PerfectServe —Remote
- $60,000 - $75,000 a year
- Remote
- Microsoft Word
- Travel
- Entry level
- Paid holidays
- Disability insurance
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Consultant
BGBx Consulting —Washington, DC
- $118,000 a year
- Hybrid work
- Bachelor of Science
- Mid-level
- Office
- Paid holidays
- Health insurance
Managing Director, Medical Affairs Consulting
Red Nucleus —Remote
- Full-time
- Remote
- Microsoft Excel
- Writing skills
- Bachelor's degree
Associate Consultant - Entry-Level Technology Consulting (Life Sciences)
Veeva Systems —Boston, MA
- $80,000 a year
- Full-time
- Hybrid work
- Office
- Travel
- US work authorization
Ambulatory Clinical Documentation Integrity Specialist (Remote)
Trinity Health —Livonia, MI
- $75,592.71 - $113,389.06 a year
- Full-time
- Remote
- Nursing
- Mid-level
- Analysis skills
Technical Writer, Contract
Therabody Corporate —Remote
- $55 - $75 an hour
- Contract
- Remote
- 5 years
- English
- Mid-level
Quick Apply
Medical Device Engineer or Materials Scientist (Implantable Device Degradation)
Tunnell Government Services —Washington, DC
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- System design
Quick Apply
10d
Trucking Safety/Compliance Expert
Dane Street, LLC —Houston, TX
- Remote
- Data analysis skills
- Analysis skills
- Senior level
Quick Apply

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Medical Device Decontamination SME

Tunnell Government Services -
Washington, DC

Quick Apply

Job Details

Qualifications

Radiation safety procedures
Steam sterilization
Stability testing
Bachelor's degree
Decontamination
Disinfecting cleaning technique

Full Job Description

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

FDA CDRH – Medical Device Decontamination SME Position Description

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.

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.

Quick Apply

Refine Your Search

medical device consulting jobs

Medical Device Decontamination SME

Program Manager, Medical & Scientific Affairs (IVD, Medical Device)

Document Control Specialist - Medical Device #2902

Senior Research Scientist, Medical Device Security Analysis

Associate Director/Director - Analytics Consulting - Medical Device

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Medical Spa & Wellness Clinic Partnerships Executive

Quality Engineer II - Medical Device #0959

Patent Analyst - BIOMEDICAL/MEDICAL DEVICES

Associate Consultant

PCT Patent Analyst (Contract) - Mechanical/Medical Devices

Product Owner

Implementation Consultant I - US Remote

Consultant

Managing Director, Medical Affairs Consulting

Associate Consultant - Entry-Level Technology Consulting (Life Sciences)

Ambulatory Clinical Documentation Integrity Specialist (Remote)

Technical Writer, Contract

Medical Device Engineer or Materials Scientist (Implantable Device Degradation)

Trucking Safety/Compliance Expert

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