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Recent Fda Compliance Inquiries

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510k

This is an independent consultant/reviewer position: requirement for a senior level person with 15+ years of experience in 510(k) medical device submissions. Individual should possess an extensive knowledge of 510(k) submission requirements to include format, content, and fda compliance requirements for class i and class ii devices by specific product code. Work entails submission reviews from a fda perspective and covers all ode branches. This work can will be performed remotely.

  1. Profile Picture

    Daniel |Clinical Scientist, Regulatory Affairs C

    Dear Mr./Mrs: Is this project for work as FDA reviewer? Regards Daniel Ramirez ...

    16 Minutes Later
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    Cynthia |Regulatory Affairs Consultant

    I am an independent medical device *****ultant specializing in class I and II medical devi...

    21 Minutes Later
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    Georganne |Consultant

    I am sure I could assist this client. I am an independent consultant with over 37 years of regulat...

    32 Minutes Later
+20 Other Responses
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Fda Compliance

Need a special 510k filed with all the proper tests for our implantable medical device? Immediate need!

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    New |

    Hello, I was a study director for long-term implantable products and handled ***** (in-v...

    2.6 Hours Later
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    Prabodh |Sr Manager R&D

    I have over 25 years experience in medical devices. I have experience in the areas of FDA and CE reg...

    2.8 Hours Later
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    James |CEO

    To Whom it May Concern, I have over 15 years of 510(k) experience. I am a former reviewer for the ...

    2.8 Hours Later
+21 Other Responses
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Fda Compliance

We are a small implantable medical device company in ny in expert of an fda compliance expert who can assist us with an upcoming audit.

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    Marie |Regulatory compliance/Quality System/ASQ

    Hello: I believe I can assist you with your audit needs. I have worked with small device companies...

    1.3 Hours Later
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    Scott |Consultant / Owner

    Hi, I have implemented several FDA compliant systems. If you could provide more ***** wou...

    1.3 Hours Later
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    Eugene |Scientific Director

    My company can do it. We are Auditors from Europe ...

    1.4 Hours Later
+17 Other Responses
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Fda 510k

A company that makes personal lubricant class ii medical device is looking for consultants with personal lubricant 510k submission experience

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    John |Owner and Sr. Consultant

    My ***** filed numerous personal lubricant 510(k)s. We would be pleased to do this work on ...

    1.5 Hours Later
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    Anne |Zintro Expert

    I have worked on many 510(k)s for medical devices (class II). I am a medical writer based in Chicago...

    2.2 Hours Later
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    Diane |Zintro Expert

    As a former FDA reviewer and 15+ years of experience in the medical device industry preparing 510Ks ...

    9.1 Hours Later
+10 Other Responses
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Fda Pre-submission

Hi! we need a pre-submission to define the regulatory strategy for an innovative yet simple electrical non invasive medical device serving an under served population of patients. I understand that you might need more details, but i just want to check if the pricing is within our budget. Please let me know what will be your ballpark quote (or price range) and timeline for the following. If your price range is within our budget, i will contact you to move forward with the project. 1. Advising on what things will be needed for preparing a pre-submission. 2. Preparing all sections of the pre-submission. 3. Corresponding with the fda and answering all questions on the pre-submission. 4. Scheduling a meeting with the fda and discussing questions that need to be clarified to clearly define the regulatory strategy (eap/denovo/pma, etc). 5. Creating a final report for lir on regulatory path and testing needed, moving forward, based on the discussion with the fda. Also if we need a 510k. What are the typical timeline and rates for a 510k? Thanks a lot! sumi

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    Alan |President and Senior Consultant

    Dear Sumi, I would be happy to help, and have a background both in such medical devices (including t...

    4.2 Hours Later
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    steve |ceo

    Hi Sumi, We are happy to help, having accomplished over 230 successful medical device submissions to...

    4.3 Hours Later
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    Les |Principal

    Hi Sumi, I can assist you with your project. I have more than 40 years of experience and have a su...

    4.6 Hours Later
+15 Other Responses
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Fda Compliance

I am looking for speaker/consultants form fda compliance industry who are ex fda's . Please drop me a message if this is suitable & this is for engagement in 2015 .

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    Timothy |Principal

    I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

    5.2 Days Later
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    Mithilesh |Advisor

    I am not from FDA. However, have more than 30 years experience in Pharma Sector & presently working...

    5.7 Days Later
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    Balvant P |PRESIDENT

    I have a proven expertise / experience in the overall areas of Quality (QA/QC) / FDA's GxP Complian...

    5.8 Days Later
+5 Other Responses
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Fda 510k Filing

I need an independent consultant to file substantial equivalence 510 k with fda

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    Polina |Zintro Expert

    I support 510K fillings for drug products. Email me at ***** ...

    1.6 Hours Later
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    Ee Bin |Owner & Consultant

    Hi there, is it a device or drug or *****ce or IVD? cheers, Ee Bin www.access2hc.com...

    2.6 Hours Later
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    Parul |Regulatory Consultant, Elexes Inc.

    I would love to help you on this. I have done a number of 510(k) fillings and successfully gotten FD...

    5.3 Hours Later
+29 Other Responses
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Fda 510k

I need someone to write a fda 510k for a class ii product.

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    James |CEO

    To Whom it may Concern, I have 15+ years working with Class II medical devices. I have worked with ...

    4.3 Hours Later
  2. Profile Picture

    Andrea |Principal Consultant

    Good Afternoon, I have about 20 years of experience in medical device *****irs, I can wri...

    4.7 Hours Later
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    Paul |CEO and Co-Founder

    Please contact our in-house *****irs expert, Rich Anderson at (916) *****....

    4.8 Hours Later
+24 Other Responses
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Fda Medical Device

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

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    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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Fda 510k

We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.

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    Ana Maria Saaibi |Director of Regulatory Affairs

    Hi, We are a consulting company with more than 7 years of experience in *****irs for medic...

    2.8 Hours Later
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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent consultant specializing in class II 510(k) submissions. Please contact m...

    6.3 Hours Later
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    Courtland |CEO

    Please let us know how we can assist you. Our firm is celebrating 11 years. Our average age in i...

    6.6 Hours Later
+14 Other Responses
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Fda Compliance

Looking for a former fda compliance expert in drugs specializing in data integrity and quality metrics. This engagement is for october 2016

    +undefined Other Responses
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    Medical Device Regulatory Affairs & Quality Assurance

    To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered. Job responsibilities: manage daily activities of regulatory affairs and quality assurance personnel implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products qualifications: **must haves** bachelor’s degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required. Must have direct, lead role fda/iso audit experience must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process. Location: greater philadelphia area, pa

      +undefined Other Responses
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