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Recent Fda Qsr Inquiries

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Quality Management System

Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey description: the manager, quality assurance & regulatory compliance will ensure overall quality management system (qms) compliance with applicable regulatory and statutory requirements. The successful candidate will manage the manufacturing site’s internal and external audit functions and will coordinate activities of third party audits /visits. In addition, the manager, quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions. Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following: *ensure overall qms system compliance with applicable regulatory and statutory requirements. *perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso 13485:2003, 93/42/eec and other applicable standards to ensure corporate and regulatory compliance *develop and conduct effective training programs on related qa topics. *conduct and support benchmarking activities. *identify areas of opportunity and support continual improvement of the quality management system identify, develop, and report qms metrics. *manage internal audits, capa system, complaint handling (investigation/resolution), document control. Requirements: a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired. Ideal candidates should also possess the following skills/experiences: applied understanding of cgmps, iso 9001, iso 13485, and fda qsr. *demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as ms project. *demonstrated experience developing quality management systems, designing and developing training programs/courses. Experience with lean and six sigma methodology and tools. *demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military, aerospace, automotive).

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    Mark |President

    Please consider AlvaMed if your client requires contract support in the short-term before they are a...

    1.4 Days Later
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    Erik |Manager

    This sounds interesting. It's a pitty that I can't meet up in person for a chat, since I am seeking ...

    2 Days Later
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    Andrea |Principal Consultant

    Hello, I have 18 years of experience in medical device Quality Systems and *****irs. Wou...

    3.5 Days Later
+5 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
  2. Profile Picture

    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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Online Medical Training

Hi all, i am looking for speakers/experts for online training in the below areas: medical device fda compliance pharmaceuticals biotech lab if you are interested, please leave your contact details and convenient time to connect. Best regards, rahul

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    Nicholas |Director R&D

    I have been in the medical device and pharmaceutical industries for over 40 years. Included many e...

    41 Minutes Later
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    Diane |Sr. RA/QA Consultant

    Dr. Diane Sudduth ***** (best time to contact after 4pm EST) Fluent in medical device quality...

    41 Minutes Later
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    David |Industrial support and development

    Hi, I have an extensive experience in medical devices (orthopedic and neurostimulation), both in va...

    42 Minutes Later
+30 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 |Dir. of Outsourcing and SCM

    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 QA/RA Consultant

    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

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

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    Tye |Principal

    My consulting firm, Spillum & Associates, LLC provides leadership & support of FDA enforcement & rem...

    5.5 Hours Later
  2. Profile Picture

    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    5.8 Hours Later
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    Courtland |CEO

    Please let us know if we can assist you with your project. We are well established in the industry ...

    6.2 Hours Later
+8 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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    Yevgen |Scientific Director

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

    1.4 Hours Later
+17 Other Responses
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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.

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    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 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 Compliance

Looking for fda compliance expert with minimum of 15 years of experience to be a consultant speaker.

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    Darshan |FDA Regulatory & Compliance Attorney

    Can you be more specific on the type of compliance expertise you are looking for?...

    2 Hours Later
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    Courtland |CEO

    I have 33 years of experience on GMP compliance. I have a group of friends (mainly ex FDA) that can...

    2.2 Hours Later
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    Sue |Team Lead - US Complaints Operations

    I have drafted responses for 483 ***** ***** and responses and presented directl...

    2.5 Hours Later
+12 Other Responses
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Fda Compliance

We are a small startup medical device company and are getting ready to start production of an fda class 1 device. We need a consultant to help us file the necessary documentation with the fda and iso, and to establish a small production facility in northern nj

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    Plamena |President & Principal Consultant

    Our consultancy will be happy to assist with your project. We have experience with class I devices ...

    1.7 Hours Later
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    Monther |President

    Hi. I'll be glad to assist you in the ***** being in compliance. Launching class I devic...

    1.8 Hours Later
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    Denise |Senior Consultant

    Happy to help. Our company specializes in helping small start-ups. ...

    1.9 Hours Later
+22 Other Responses
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Fda Compliance

Manufacturing a skin cream. Not otc, no apis. Purpose is the transdermal delivery of l-arginine. Have ingredients list. Need product label review.

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    Michael |Senior Principal Consultant

    Sounds an easy phone consultancy and would love to assist...

    50 Minutes Later
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    Courtland |CEO

    We review many labels each week. Let us know if we can assist you in this matter....

    54 Minutes Later
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    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    55 Minutes Later
+17 Other Responses
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Fda Compliance

Dear sir i am a quality assurance manager of one of the biggest pharmaceutical company in turkey. I am looking for a fda compliance consulting company to assist us for fda approval process.

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    Cynthia |Executive Vice-President

    Please allow this note to introduce my company, American Technical Consultants to you. I am sure we...

    5 Minutes Later
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    Anastasia |Consultant-Microbiologist

    Is this for a sterile drug, solid dosage form, generic or brand name, biotech or small molecule? I c...

    9 Minutes Later
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    Maha |Senior Consultant

    Dear Sir, I believe I can help you. I am a consultant with extensive experience with the FDA approva...

    1.5 Hours Later
+19 Other Responses
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