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.+16 Other Responses
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+16 Other Responses
Medical Device Reimbursement
We are looking for reimbursement experts also called payers experts who have experience getting a medical device approved with one of the european agences such as with germany's bfarm or emea, aemps in spain, aifa in italy, nice in england, or has in france. You do not have to work for these agencies but we need someone who has worked closely with the process of getting a medical device approved with one of these agencies. The product we are working on is for chronic rhinosinusitis and the device involves a laser for the patient. We would like to interview you for one hour about this process. Please send me a detailed reply on your experience with getting medical devices approved in europe overall or in a particular country. Also do you have experience with rhinosinusitis? Please be very detailed so we can determine if you have the right experience.
Janet *****+2 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+25 Other Responses