Regulatory Affairs Specialist - Medical Devices (Hybrid)
Werfenlife SA.
Werfenlife SA. is seeking a Regulatory Affairs Specialist based in Waukesha, Wisconsin. The role involves ensuring compliance with various regulations, preparing regulatory submissions, and supporting other compliance tasks. The ideal candidate will have a Master’s or Bachelor’s degree in a related field and experience in regulatory affairs. This position offers the possibility of hybrid work, requiring the candidate to be within commuting distance to the office. Drug testing and a background check are required prior to hire. #J-18808-Ljbffr Werfenlife SA.
- Werfen is seeking a Regulatory Affairs Specialist in Waukesha, Wisconsin. This role focuses on ensuring... ...and international regulations for medical devices. The ideal candidate should possess... ...communicating with regulatory bodies. Optional hybrid work is available for those residing...Medical device
- ...content Responsibilities Regulatory Affairs Specialist . Keep abreast of new and revised... ...for Standardization) 13485, MDSAP (Medical Device Single Audit Program), IVDR (In-... ...inspections. Employer offers optional hybrid work from home within commuting...Medical deviceFull timeWork experience placementWork at officeWork from homeWorldwideShift work
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$190k - $200k
...speaking and living with a neck stoma? At Atos Medical, our people are the strength and key to... ...support, and high-quality medical devices that help people breathe, speak, and live... ...discounts. State-of-the-art facility: Hybrid and onsite employees work from our state-...Medical deviceSummer workWork at officeImmediate startWorldwideFlexible hours- ...Inside Sales (Customer Support) Representative | New Berlin, WI | Hybrid work-schedule Join usand give people a voice! In the Inside... ...experience strongly preferred. Experience in Healthcare or medical device industry preferred. Ability to recognize prospects, present products...Medical deviceTemporary workSummer workWork at officeImmediate startRemote workFlexible hours
- ...requires strong mechanical design skills and collaboration with cross-functional teams. Applicants should have experience in the medical device manufacturing sector and proficiency with CAD and ERP tools. The ideal candidate will manage project timelines, create...Medical device
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- ...manufacturer, standardizing key quality processes, and ensuring regulatory compliance. Candidates must have a bachelor's degree in IT or... ...experience, including 1 year involving FDA or EU-MDR medical device design. The position offers the opportunity to lead quality improvement...Medical device
- ...leadership on technical issues. You'll be involved in design reviews and ensure designs meet regulatory requirements, contributing to projects across various sectors, including medical devices. The ideal candidate holds a Bachelor’s in Mechanical Engineering and has over 5...Medical device
- ...environment to help us innovate in a fast-moving medical-technology landscape. Support ongoing... ...that interface with physical devices. Familiarity with continuous-integration... ...best work. #LI-LRG1 #LI-Onsite #LI-Hybrid We will not sponsor individuals for employment...Medical deviceVisa sponsorshipWork visaRelocation package
- ...The Product owner translates business, regulatory, and technical requirements into clear,... ...and schedules. Willingness to work a hybrid schedule with three days per week on-... ...in a regulated healthcare industry with medical device development with Quality Systems. ~ Demonstrated...Medical deviceTemporary workWork experience placementWork at officeVisa sponsorshipWork visaRelocation package3 days per week
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- ...algorithms used in regulated medical devices. The engineer bridges... ...clinicians, customers, and regulatory stakeholders. Roles and Responsibilities... ...to clinical application specialists. Understand and follow GE... ...environment. Willingness to work a hybrid schedule with three days per...Medical deviceWork at officeVisa sponsorshipWork visaRelocation package3 days per week
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- ...ensure manufacturability. Ideal candidates have a Bachelor's in Mechanical Engineering and 3-6 years of experience, preferably in medical device manufacturing. Proficiency in MS Office and CAD software is required. The position offers a dynamic environment with...Medical device
- ...ideal candidate holds a Bachelor's in Mechanical Engineering with 6-10 years of experience in product design, preferably in the medical device industry. Proficiency in SolidWorks and other CAD tools is essential. Responsibilities include developing product designs,...Medical device
- ...is seeking a skilled FPGA Engineer specialized in VHDL for medical devices. You will be part of an Agile team tasked with developing healthcare... ...high-speed data paths, and ensuring compliance with regulatory standards. Strong experience with FPGA design using Xilinx or...Medical device
- ...oversee governance of quality improvement projects to ensure regulatory compliance. Minimum Requirements: Must possess bachelor’s degree... ...least 1 year working with FDA or EU-MDR Class I or Class II medical device design and development. #J-18808-Ljbffr Banque...Medical deviceWork experience placement
- ...Experience developing new product designs across the product lifecycle (concept through validation and release) Experience in the medical device manufacturing industry or knowledge of injection molding design and related manufacturing processes Strong mechanical design...Medical device
- ...delivers reliable, real-time performance for highly sophisticated medical devices, while exploring how modern AI-assisted approaches can... ...knowledge and upholding coding standards, best practices, and regulatory expectations Contribute within a Scaled Agile Framework (...Medical device
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- Keywords: Lab Technician, test set up, troubleshoot, system installation, test result document, medical device Please share the profiles with assembling, dismantling and prepare test setup and testing experience. Job Overview: Utilizing initiative and independent judgment...Medical device
- ...of training and experience. ~6 to 10 years of work experience developing new product designs in similar industry is required; medical device experience preferred. ~ Knowledge of MR physics, pulse sequences and electro-magnetic field theory is required. ~ Hands-on...Medical deviceWork experience placementLocal areaRelocation package
- ...using C++, CUDA, and HLSL, with a special emphasis on image processing and software development for General Imaging Ultrasound medical devices. You will design and develop software platform components with scalable architecture, collaborate with internal Subject Matter...Medical deviceWork at office3 days per week
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