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
+25 Other ResponsesMedical 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!!
+17 Other ResponsesWound 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
+13 Other ResponsesImplantable Device Oem Market
We are looking for multiple experts who can talk about technology that interfaces with implantable devices to control the implant, track data, and/or be a two-way channel to review and react data from the device.
We are interested in individuals who can discuss about device product or engineering of medical devices original equipment manufacturer (oem) seeking food and drug administration (fda) approval.
This is a paid 1-hour phone consultation. Please provide a brief answer as to your relevance to the space below:
1. Are you able about speak about the market growth or development of internet of healthcare things (ioht) for devices interfacing with implantable devices?
2. Can you speak about specific use cases of this technology and how it is likely to evolve in the market?
3. Can you speak about the landscape of different types of technology providers in this space?
+5 Other ResponsesImplantable Device On Telecom Channels
We are looking for multiple experts who can talk about technology that interfaces with implantable devices to control the implant, track data, and/or be a two-way channel to review and react data from the device.
We are interested in individuals from the heatlhcare buying groups who can discuss the factors to consider in deciding the technology and the medical device original equipment manufacturer (oem to partner with.
This is a paid 1-hour phone consultation. Please provide a brief answer as to your relevance to the space below:
1. Are you able to speak about the fda approval process specific to the security protocol relevant to the technology for data management that interface with implantable devices?
2. Can you discuss the outlook for these types of devices?
3. Are you part of the decision-making team in choosing the technology and medical device original equipment manufacturer (oem to partner with?
+3 Other ResponsesMedical 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
+29 Other ResponsesOnline Pharmaceutical & Medical Devices Market
Need an expert who would be able to assist on the global online pharmaceutical and medical devices market. The key data points that i would like to discuss our:
- evolution of the online sales of pharma and med devices
- key driving factors and challenges
- split of offline and online share pharma and med devices
- geographic split of the online market of pharma and med devices
- operating model of companies
- type of products sold via the online channel
- split on type of customers purchasing via the online channel (b2c, b2b)
- future landscape of the online channel
we need to understand the global perspective on the study.
+29 Other ResponsesCombination 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.
+16 Other ResponsesFda 510k
We're looking for a remote fda 510k consultant who can help us with medical device 510k submission advice and iso13485 certification. In terms of requirements, we're already taking on board advice to help us get through regulatory hurdles with the tga and ce marks and are fully aware of our requirements and on the way to getting our technical file ready.
Our devices are class 2 devices:
-a device which converts any bed into a hospital bed (with motors and a frame that adapts to your current bed)
-one which monitors movement patterns and vital signs non invasively, as you lay on it.
Our app takes in inputs from this, and, perhaps, in the future, other devices too and processes them into alerts that are sent out to loved ones/caretakers. Both are a fraction of the price of current offerings, and aimed at a b2c market.
To qualify, please provide your feedback on the following.
-have you worked with fda 510k submission in the past?
-have you worked on ce marks/tga and other regulatory bodies globally too.
+20 Other ResponsesMedical 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.
+35 Other ResponsesMedical 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 ResponsesFda 510k
Looking for a seasoned 510k submission expert with significant proven experience with ivds.
- need someone with experience in the gastrointestinal space, medical devices and colonoscopy.
+7 Other Responses
