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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
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Recent Medical Device Inquiries

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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

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    Medical Device 510k

    We are a contract manufacturing company. We have a medical device manufacturing license from the state of california. We manufacture private label personal lubricants that now require 510k approval by the fda. Our customer that we manufacture the lubricants for has gotten 510k approval on his product, but that is only for his brand. As a contract manufacturer we must get 510k approval on our formula and list what brands we produce it under. I need a consultant that has 510k experiences.

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      Parul |Regulatory Consultant, Elexes Inc.

      I have done successful 510k submissions, and would love to do this job for you! Why am I a good fi...

      22 Minutes Later
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      steve |ceo

      HI, Happy to get your *****red through the 510k process. I and my small team have gotten ...

      25 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...

      33 Minutes Later
    +35 Other Responses
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    Combination Medical Devices

    We are using a new api as an active ingredient in a coating formulation to be applied to a wide variety of medical devices. The api elutes out slowly over time. Looking to find an expert with tox and regulatory knowledge on combination medical devices (device/drug) spanning many different fields of use: dermatology, vascular access, respiratory, orthopedic and others.

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      Design And Prototyping Of Medical Devices

      Position description: lead – ortho neuro spine department: r&d lead – ortho neuro spine will be responsible to develop strong talent to grow recon business that includes hips and knee, trauma, spine and navigation. Person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for ortho neuro spine business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 – 100 people • to ensure timely deliverables to our internal customers position description: lead – hospital infrastructure department: r&d lead – hospital infrastructure will be responsible to develop strong talent to grow hospital infrastructure business that includes patient care and handling and operating room -suite product lines. . person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for hospital infrastructure business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 –75 people • to ensure timely deliverables to our internal customers • capable of ‘thinking outside the box' • proven experience as a project lead/ manager with good supervisory and team work skills in a fast paced/dynamic environment. • have worked on r&d for operating room devices e.G. Surgical lights, video management, tele medicine, beds and stretchers

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        John |CEO

        Please contact me with this inquiry. I would consider helping your company after learning more about...

        11.9 Hours Later
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        Ade |CEO

        Hi Sheetal Thanks for the enquiry but this is not in my field of expertise. Regards Ade...

        23.8 Days Later
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        Benjamin |President/CEO

        Are you searching for an engineer or a more sales and marketing focused candidate?...

        30.1 Days Later
      +3 Other Responses
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      Medical Device Manufacturing Landscape

      Have a potential client that we may do research for. Am trying to get a feel for whether or not we can actually find them the right respondent types. They are looking to speak with key decision makers of medical device manufacturers, specifically looking to speak to them about the following: - identifying pain points, fears, uncertainties, and potential points of confusion that they can address through marketing communications - establishing the audiences that have the most interest in and need for the client's services - what motivates them, where do they get information, etc. - questions/concerns that manufacturers have about entering the chinese market and work with the cfda - general unmet needs or medical device manufacturers as it pertains to better grasping standards set for class ii or iii devices by the cfda, fda, or ema. If there is anyone that feels they might be the right person to speak with for this study, or know what title(s) we should be targeting at the manufacturers, please send me a message. Targeting key decision makers that actually work for a medical device manufacturer thank you!!

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        Wound Care Medical Device

        Subject -- wound care medical device 510k / pma hi all, we are looking for expert who has done a wound care 510k or pma submission this year or last year. We are looking for a long term engagement. We do not need help writing the submission, but we only need advise on deciding what claims we can make or not make, what type of concerns fda has expressed in the recent submissions, and will the product be subject to a 510k or a pma submission. Please do let us know your hourly rate. Thank you! jasmine

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          Courtland |CEO

          Jasmine, Our team has a wound care expert. 33 years experience. Many submissions and product deve...

          4.8 Hours Later
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          steve |ceo

          Hi Jasmine, We have a number of long term clients, start-up and well established companies to who we...

          4.9 Hours Later
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          Michael |Regulatory Project Manager

          Hi Jasmine, *****irs Associates (RAA) has successfully submitted over 200 medical device s...

          5.1 Hours Later
        +13 Other Responses
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        Implantable Medical Devices

        We would like an expert company representative from a medical product manufacturer to provide an opinion as to the representative's role in the surgery at issue to support our claim against a medical representative

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          Chris |Founder and Principle

          I am interested in helping with this request. I have lead global medical device companies as Presid...

          8 Minutes Later
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          Larry |Pharmacuetical Sales Executive

          I would love to help. I'm a registered nurse with 14yrs, worked as a clinical consultant directly wi...

          12 Minutes Later
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          James |CEO

          I have over 15 years of OR experience supporting medical device manufacturers....

          18 Minutes Later
        +15 Other Responses
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        Medical Device Manufacturing Engineering

        Job title: senior manufacturing engineer job type: full - time department: engineering reports to: director of operations location: windham, maine **job details** are you a talented optical medical device manufacturing engineer ready to develop and execute manufacturing process plans for optics component manufacturing, continuously improve processes and plans using tools and methods such as statistical process control (spc) and design of experiments (doe), and conceptualize, design and execute tooling/process requirements? If so then read on! **primary function** - provide mfg. Engineering support of multiple projects - manage apqp planning process for new programs
 - oversee design and development of new products and processes
 - conduct fmea, doe, spc analysis 
 - direct validation activities for new tools, process and equipment
 - develop and submit validation packages for customer approval
 - map work flows and develop process control plans 
- train personnel to transfer new programs to production **education and experience required** - b.S. In mechanical engineering, optical engineering, materials science, and optical engineering, physics, chemical engineering or equivalent experience strongly desired. - 5-8 years’ experience in engineering with experience in a manufacturing environment
 - product development experience specializing in medical device and life science industry - experience in development programs involving class ii & iii medical devices, 3d modeling, - drafting experience using solidworks - experience in iso13485 glp/gmp environment - experience with design tools (solidworks, cad, 6 sigma principles and practices, fmea, statistical analysis, etc.) - knowledge of design verification/validation activities (sterilization, biocompatibility, packaging, aging, etc.) strongly desired. - metal stamping or medical device experience required 
- minitab statistical software
 - apqp process expertise
 - engineering studies analysis - map process control plans
 - written work instruction level documents for manufacturing - ability to work in a team, be proactive, and proven project management skills experience. This is a growth position. If you are a talented optical manufacturing engineer with at least five years of experience working with lean manufacturing and medical devices, then we look forward to your resume! kindly attach your resume along with your response on zintro. We offer: competitive salary, paid holidays, paid vacation, medical insurance, life insurance, supplemental insurance including: dental short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k with employer contribution. Applicants must be authorized to work in the u.S.

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          Mark |Consultant

          I am very interested in the opportunity to help your company with the manufacturing of optical based...

          1.1 Hours Later
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          Benjamin |Zintro Expert

          Does this position pay $1,000,000? My current boss is the worst, I need a new opportunity....

          16.3 Hours Later
        +3 Other Responses
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        Medical Device Manufacturing

        Dear all, we are starting a medical device company related to ivd (its a blood glucose monitoring wearable). We want to make sure to do the right things from the beginning. We would request your quote and timeline on all the following: 1. 510k submission for our class ii - we want someone who can guide on 510k, write the submission, correspond with the fda and get clearance for us. 2. Quality systems- write all sops for us per the fda, train our employees on all the sops 3. R&d - write testing protocols for us, write reports for all performance/bench testing. 4. Create technical file, assist in audit and help in getting ce mark. 5. Finding the right test labs for us and managing test labs. Please advise how much would it cost for each of the above individually. We personally prefer fixed price projects. Looking forward to working with you thanks, ronen

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          Colleen |Owner

          Hello, I have had extensive experience with all of the items you have on your list. I was the Direc...

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

          Dear Inquirer, I have extensive experience in all of the areas you have requested and more. 1. I ...

          59 Minutes Later
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          Susan |President and Founder

          I would be interested to discuss further; I have experience in all of these areas. ...

          1 Hour Later
        +29 Other Responses
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        Medical Devices Product Launch

        I am looking for an expert to support the launch of a new product in europe in 3q 2012. The competitive candidate will have demonstrated expertise in international trade, customs, supply chain, logistics, distribution and insurance for class ii & iii fda/ema medical devices.

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          David |President and CEO

          Please let me help you I have over 150 510k to my credit, PMA and *****se contact me ...

          13 Minutes Later
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          Aaron |V.P. and General Manager

          Hello, My company supports companies to design and introduce products all over the world and I'm ce...

          38 Minutes Later
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          John |Consultant & Executive

          I think I can help you out. I've had a lot of experience launching medical device products in Europ...

          4.3 Days Later
        +8 Other Responses
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        Medical Device Prototype

        Looking to design and manufacture a proof of concept alpha prototype for a medical device work with compressed air and abrasive powder for a dentalooking for subject matter expert (individual, team, or company) who can design, develop and build an alpha-prototype a device for dental surgical procedure based on our ip. The device utilizes abrasive powder under pressure in a focused controlled pattern to perform the invasive procedure in oral cavity. The rfp will include the design and alpha prototype, manufacture of 1) a handheld operative hand piece or “working head” and 2) a controlled “pneumatic power control unit” which would include compressed air and vacuum source, abrasive powder distribution reservoir, rinse system (reservoir and pump), pressure/vacuum gauges analog or digital, regulators, control valves, control panel, fittings/tubing, electrical wiring and chassis. Required expertise includes but not limited to • cad design through solidworks or similar software to prepare a 3d design of the assembly and components/subassembly prints for manufacturing • mechanical engineering, r&d, and product development experience preferably in the medical device industry. • innovative strategist and problem solver who can develop customized, effective solutions to meet needs in challenging user requirements and mitigate procedural risk through design. • ability to coordinates manufacturing/assembly, and testing to achieve client’s objectives on time, within budget, and to specification. • fluidic designs: such as micro-fluidics, valves, manifolds, pumps-(e.G. Precision aspirate/dispense, diaphragm, solenoid, syringe, piston) reaction and mixing chambers, flow-cells, aspirate/dispense probes, fittings, tubing, flow calculations. • pneumatic design: pneumatic power modules, motion/transfer devices, valves, manifolds, fittings, tubing, compressed air calculationsl procedure. Need a consulting firm who can develop a cad design, perform engineering analysis, prepare specifications of the design and source manufacturing of the alpha prototype and test the device for expected performance

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          Shinoop |CEO

          I am a industrial designer. Since last four years i am professional in Autocad and solidworks 3D mo...

          1 Minute Later
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          Guillermo |Software Developer

          I can help you in developing software for medical ***** you need it, we specialize in de...

          1 Minute Later
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          Pete |Innovation Consultant + Principal

          Hi. I'm a product *****ultant that specializes in the design and development of new produ...

          1 Minute Later
        +16 Other Responses
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        Medical Device Ophthalmology

        We are currently seeking for an ophthalmology distributor in europe, latin america, and asia. **********, inc. Is a united states manufacturer marketing sterile and non-sterile proprietary class i and class ii medical devices for use in cardiovascular surgery, iv fluid delivery and ophthalmic procedures. Our focus is providing better outcomes through design, development, manufacturing and distribution of superior products to advance the standard of care and increase safety. Our ophthalmology product line the ******* ********* balloon catheter has revolutionized the treatment of blocked tear ducts (chronic epiphora and nasolacrimal duct obstruction) in children and adults.The ********* balloon catheter is used in a similar manner as ordinary probing with the added benefit of an expandable balloon. The catheter also provides more options to patients who have been told only an incisional dcr surgery will solve their blocked tear duct and chronic tearing problem. This patented ophthalmology surgical instrument and balloon technology means that patients can achieve highly effective results while reducing the trauma they experience. Doctors using ******* medical ophthalmic surgical equipment, including the ******** balloon catheter, will find they are easy to use and provide a cost effective treatment for blocked tear ducts (chronic epiphora) in both pediatric and adult patients. Please contact me if you are interested.

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          Marc |President, VP, Direcotr

          Thank you for your request. Unfortunately I am not a distributor. I am a consultant who assists in s...

          3.6 Hours Later
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          ZVIKA |Senior executive / consultant

          Having setup and managed world-wide distributors' net-works for many sided medical devices, I might ...

          10.9 Hours Later
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          Krzysztof |

          How can I help&advise concerning Polish market ? Best regards, Krzysztof Przybylski ...

          5.8 Days Later
        +6 Other Responses
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        A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).

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