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!!+undefined Other Responses
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.
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
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
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.+14 Other Responses
Medical Device Manufacturing
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
ronen+29 Other Responses
Medical Device Marketing And Strategy
We are looking for a medical device professional, with a strong background in emergency medical/first responder devices, to help a start-up company develop strategy, valuations and ultimately a licensing agreement, or other arrangement, with a mid-size or major medical device company. Patents, trademarks, preclinical trials (highly successful) and fda pre-market applications either in place or in process. Greater los angeles area preferred.+4 Other Responses
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.+11 Other Responses
Medical Device Fda Audit
We need an immediate gap analysis performed in the philadelphia area for an upcoming fda audit. We are a start up impant company (2 years) that needs to tighten up our procedures. Hot request+42 Other Responses
Medical Device Remediation
Qa remediation compliance consultant (with german /italian)
following gap analysis of 100+ pharmaceutical manufacturing distribution centre documentation files, a qa consultant is required to review, sanitise and remediate 2 year-old files in line with fda regulations. This major top-10 pharmaceutical / devices company works in developing innovative medical devices, biopharmaceutical medicines, vetinary products and orthopaedic products. This is a long-term contract (up to 12 months) and the main purpose of the role is producing remediation complaint & non-conformities reports received by distributors.
ï· qa compliance experience, specifically in a medical device regulated environment for fda
ï· high understanding and know-how of fda regulations
ï· knowledge of remediation minimal requirement versus remediation expanded requirements
ï· able to work autonomously in a production environment, and independently able to retrieve information needed
ï· ability to deliver in accordance to timeframe target of single ncr remediation
ï· capacity of delivery facing âlimited data availableâ cases. Pragmatic ï· hands-on role. No management responsibilities.+7 Other Responses
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.+8 Other Responses
Fda Medical Device
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.
jorge+34 Other Responses
Fda Approval For Medical Device
Mechanical facial stimulation on the skins surface.Natural. Targeted cellular response and lifting effect.
Non invasive non agressive.+4 Other Responses
Wound Care Medical Device
Subject -- wound care medical device 510k / pma
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.
jasmine+13 Other Responses