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Recent Medical Devices Development Inquiries

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Medical Device Materials Science

Our client manufactures, markets, and sells gi endoscopy tools and accessories in the chinese and international markets. Client is currently seeking 2 candidates that can spend up to a year based in their facilities in china, to assist the company in the manufacturing of a new medical device (in the interventional radiology space) that requires polymer chemistry and/or materials science expertise. The assignment would likely begin in q1 or q2 of 2015. Compensation package to be determined. Job function: the candidates will be responsible for: - developing a major project design for manufacturing of a new medical device - developing the scale up process for biomaterial synthesis associated with this device qualification requirements: candidates should have a phd degree in polymer chemistry or materials science, and have a strong interest for interdisciplinary work in the field of medical technology. They should have experience in material synthesis and characterization. Thank you. Ron

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    Guillermo |Software Developer

    Maybe your product or another pruduct in the future, may require experts with doctoral training in B...

    40 Minutes Later
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    Bob |Research Associate

    Hello Ron, I am very interested in this position and would like to discuss the details, if possible....

    2 Hours Later
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    Peter |President

    Hi Ron, I'm an expert in ***** medical device with experience of 20 yrs in top US medica...

    6.4 Hours Later
+16 Other Responses
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Fda Medical Device

Hello, my name is jorge and i am trying to start a small company oriented to import and distribute medical adaptors such as omheda and many others in the us and eventually internationally. I am just exploring the requirements such as a cleanroom (or any other thing needed) and certifications in order to be able to operate. That is why, in order to analyze if we are able to do this, i need some guidance or information in regards to this in order to be aware of exactly what do i need to do to market these products in full compliance with the fda regulations. I would very much appreciate your help and any information to make this clear in order to proceed. Kind regards, jorge

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    Darren |President - Owner

    I can help support this project but need the details to ensure products are legally marketed. Pleas...

    1.1 Hours Later
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    Suzanne |CEO

    Dear Jorge, We might be of support to you. Just contact us with what you exactly need and we will ge...

    8.2 Hours Later
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    Seth |President

    Good Morning. I am former US FDA and frequently advise on making sure imported products meet require...

    10.8 Hours Later
+34 Other Responses
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Fda Medical Device

We are looking for a fda consultant in south carolina

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    Cindy |Principal

    HI, Could you tell me more specifically about the type of work? It will give me insight into wheth...

    29 Minutes Later
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    Dierdre |Partner

    Please let me know the ***** the device and ***** long a committment is required....

    11 Hours Later
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    Scott |Consultants

    We have a very strong medical device *****ulting practice with seasoned consultants well v...

    12.9 Hours Later
+10 Other Responses
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Fda Medical Device

I need help filing a special 510k for my product. Thank you

  1. Profile Picture

    Larry |Served as CEO, VP Sales and Marketing, R

    Hello, I am an FDA *****irs Consultant. I prepare Special FDA 510(k) submissions for Medi...

    7 Minutes Later
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    Les |Principal

    I can help you with this as I've successfully submitted numerous 510(K)s. Please contact me at fdaq...

    10 Minutes Later
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    NO WAY TO |Chief Experience Officer

    We can help with the usability aspects iso ***** for your 510k by conducting and reporting on your s...

    16 Minutes Later
+13 Other Responses
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Bio Material Process Engineering

Looking for a process engineer with 10 years of experience who is comfortable evaluating demonstration for verification of scale up performance (yields, etc). Prefer someone with bio-based materials experience.

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    John |Senior Research Fellow

    I'm more in pilot process development, hence I'm probably not the guy you're looking for. However, I...

    2.8 Hours Later
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    Karl |CSO, Director of R&D

    I have 30 years of experience with collagens and *****ugh to clinical trials and am interes...

    2.9 Hours Later
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    Karla |Zintro Expert

    I have experience in bio based *****...

    7.2 Hours Later
+9 Other Responses
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Fda Medical Device

We are in search of an expert witness who can evaluate whether a medical device company complied with fda regulations in validating products before shipping for commercial use. Former fda auditor preferred.

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    Les |Principal

    I can absolutely help you. Please check my website, www.quality-docs.org to view my credentials. P...

    7 Minutes Later
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    Shailesh |Practice Manager

    Hi there, I can help you in this area. I work with a company which provides this service. Kindly l...

    11 Minutes Later
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    Timothy |Principal

    I am former FDA, engage in device and drug/device *****tegy, perform device Quality System...

    13 Minutes Later
+14 Other Responses
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Fda Medical Device

Assist with preparation of description of inhalation device, for submittal to fda, and perhaps later assistance with fda process. Someone with existing expertise with inhalation devices.

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    Joseph |Plant technical manager/ Owner consultin

    I can help with consulting for FDA compliance documents for *****ces. Could we have a qui...

    52 Minutes Later
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    Leona |President and Principal Consultant

    Hello I would be able to assist you. My Bio is below: Dr. Saunders is a Specialist in Science & Reg...

    1.9 Days Later
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    Andrea |Medical Liaison/Consultant/Physician Ass

    Thank you for contacting me regarding FDA submissions for an *****ce. Please provide me w...

    2.8 Days Later
+3 Other Responses
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Fda Medical Device

Looking for 20 plus years of experience to schedule webinars and share the knowledge

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    Eugene |President/Chief Consultant

    Can I be of help to you? I was the Product ***** Product Jurisdiction officer for CDRH from 199...

    2.4 Hours Later
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    Thomas |Product Safety and Approvals Consultant

    I am pleased to have the opportunity to offer this proposal to you. I have been involved with regula...

    5.6 Hours Later
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    Les |Principal

    I have more than 35 years of experience in the medical device arena. I would be happy to have an in...

    1 Day Later
+6 Other Responses
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Fda Medical Device

*******, a class 3 medical device startup company is looking for and experienced chief operating officer with experience of taking a medical device from startup to fda approval.

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    Ron |I have held the following titles, Presid

    I saw your post seeking someone with medical device start-up expertise. I have that experience and w...

    38 Minutes Later
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    Mark |Executive CEO/ GM/ Interim Executive

    Hi, thank you for the inquiry. While I am an experienced COO of start-up(s) and *****-t...

    1.7 Hours Later
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    Michael |Principal Consultant

    What therapeutic focus? I have experience with orthopedics. Mike...

    3.2 Hours Later
+11 Other Responses
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Fda Medical Device

Need an expert on the reasons for and uses of data collection related to the used of a medical device after trial completed but before marketing approval under continued access

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    Sujatha |Clinical Affairs Manager

    I have done a continued access for a medical device and can discuss the pros and cons if you are int...

    6.4 Hours Later
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    Peter |COO

    Can you be slightly more specific and descriptive as to what your need is. Peter...

    7.1 Hours Later
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    Jim |Principal

    I have expertise in this area....

    7.6 Hours Later
+10 Other Responses
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Fda Medical Device

Need a consultant for combination product guidance for fda submission

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    Lee |President

    I am a consultant with significant, recognized experience and expertise in *****ucts and ...

    20 Minutes Later
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    Michael |Regulatory Project Manager

    *****irs Associates (RAA) is a premier consulting firm. RAA has completed over 200 succes...

    33 Minutes Later
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    Plamena |President & Principal Consultant

    I have specialized in *****ucts in the past 8+ years and sit on the AAMI working group, a...

    3.4 Hours Later
+14 Other Responses
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Fda And Medical Devices

Hi, this is ranjan from complianceonline (training and coaching) on fda and medical devices. I would like to invite you as a speaker with our company on online webinars. Kindly let me know would you be interested as a speaker/expert and provide trainings. Thanks & regards, ranjan

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    David |Director of Quality Assurance

    I would like to hear more about this project. ...

    15 Minutes Later
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    Mark |Clinical Associate Professor, Oregon Hea

    Hi Ranjan, Yes, I'd be interested. Please forward further information....

    19 Minutes Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Ranjan, I would be interested. Sushma has already scheduled a "Discovery Call" meeting on 5/21...

    19 Minutes Later
+33 Other Responses
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