Global Medical Device Regulatory Affairs Specialist
Katalyst CRO
A leading clinical research organization in the United States is seeking a Regulatory Affairs Level III (Senior Specialist) to ensure global product registrations and compliance in the medical device sector. The candidate will oversee regulatory strategies, prepare product registrations, and support audits and inspections. Ideal candidates will have a Bachelor of Science degree and 5-7 years of experience in regulatory affairs, specifically in medical devices such as respiratory devices. Strong analytical and communication skills are essential as well as knowledge of ISO and FDA standards. #J-18808-Ljbffr
- ...Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance... ...in the design, manufacturing, and sales of medical devices (including Class I and II devices,...Medical device
- ...Regulatory Affairs Level III (Senior Specialist) The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance... ...manufacturing, and sales of medical devices (including Class I and II devices...Medical device
- ...This role is responsible for Regulatory Affairs support of submissions and... ...positive relationships with device reviewers through oral and written... ...for compliance with global regulations; analyze and recommend... ...g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility)...Medical deviceWork experience placementWork at office
- ...Regulatory Affairs Associate The Regulatory Affairs Associate will be responsible for managing... ..., including Class III implantable medical devices. This position involves coordinating cross... ...and acceptance requirements for global regulatory authorities. Manage multiple...Medical device
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high‑tech applications, is currently seeking a Quality Control Lead on 1st shift. If you are motivated by new opportunities...Medical deviceWork at officeFlexible hoursDay shift
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is currently seeking a Press Operator on 1st shift. If you are motivated by new opportunities...Medical deviceFlexible hoursDay shift
- Viltis is seeking a Design Engineer for a 6-month contract based in Richmond, IL. This role involves supporting medical device product development and ensuring compliance with design control requirements. Candidates should have a Bachelor's degree in Engineering, with...Medical deviceContract work
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is currently seeking a CNC Machinist Programmer on 2 nd Shift . If you are motivated by new opportunities...Medical deviceFlexible hoursShift workAfternoon shift
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is currently seeking a CNC Machinist Operator on 2nd & 3rd Shift. If you are motivated by new...Medical deviceFlexible hoursNight shiftAfternoon shift
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is currently seeking a Manufacturing Manager. If you are motivated by new opportunities and business...Medical deviceWork at officeFlexible hours
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is... ...production order requests from Account Specialists and develop schedules based on capacities...Medical deviceWork at officeFlexible hours
- ...Brunk Industries, Inc., a globally recognized company specializing in high precision metal components for the Medical Device Industry as well as other high-tech applications, is currently seeking a Business Development Manager. If you are motivated by new opportunities...Medical deviceContract workWork at officeFlexible hours
$140k
...Medela LLC is seeking a Senior Product Manager for their Medical Devices SaaS & Connectivity solutions. This is a hybrid role with expectations... ...Responsibilities include leading product strategy, managing global product lifecycles, and developing business cases. A...Medical device- Viltis in Richmond, IL is seeking a Histology Technician for a 6-month contract to support medical device research and manufacturing science. The ideal candidate will handle tissue processing, microtomy, and staining in a regulated environment. This role requires a minimum...Medical deviceContract work
- ...distance to McHenry. The position involves leading the design and development of embedded electronic systems for next-generation medical devices. The ideal candidate has over 5 years of experience in electronic systems, a Bachelor's degree in Electrical Engineering, and...Medical device
- ...Development Engineer – Electronics. In this hybrid role, you will lead the design and development of embedded electronic systems for medical devices that improve lives. You will work collaboratively with various engineering teams and drive projects from concept through...Medical device
- Histology Technician (Contract) - Medical Device Laboratory Location: Richmond, IL Duration: 6-Month Contract (March 2026 - End of 2026) Schedule: Full-Time, 40 Hours/Week, Monday-Friday Day Shift Department: Manufacturing Science & Engineering Position Overview We are...Medical deviceFull timeContract workMonday to FridayDay shift
- ...seeking a Senior Product Development Engineer focused on Electronics to design embedded electronic systems for next-generation medical devices. The position offers a hybrid work model, requiring 3 days on-site. The ideal candidate has over 5 years of experience in developing...Medical device
$70k
Associate Sales Representative - Medical Device SalesAtlanta, GA | Extensive Travel Throughout the East CoastBase Salary: $70,000 + $10,000... ...OutLaunch or accelerate your medical device sales career with a global industry leaderExtensive field training and mentorship from...Medical deviceLocal areaNight shift$140k
...Senior Product Manager, Medical Devices SaaS & ConnectivityMedela LLCMcHenry, ILHybrid Work Schedule, 3 days a week on-site in McHenry, IL... ...technology-driven Senior Product Manager to lead the evolution of our global device + connectivity ecosystem, with a strong focus on the U...Medical deviceLocal area3 days per week$110k
...the design and development of innovative global healthcare education programs focused on... ...cross-functionally with Marketing, Medical Affairs, and Commercial teams to align education... ...Experience working within healthcare, medical device, or healthcare professional education...Medical deviceLocal area- ...installing, repairing, and maintaining complex medical imaging equipment. The position involves ensuring regulatory compliance, managing customer relationships, and... ...inspections and maintenance on varying medical devices. The ideal candidate will have extensive experience...Medical device
$110k
...the design and development of innovative global healthcare education programs focused on... ...cross-functionally with Marketing, Medical Affairs, and Commercial teams to align education... ...Experience working within healthcare, medical device, or healthcare professional education...Medical deviceLocal area$140k
...Medela LLC in McHenry, IL is seeking a Senior Product Manager specializing in Medical Devices, SaaS, and Connectivity. This hybrid role involves leading product lifecycle management for devices and solutions in NICU and maternity care, with a focus on innovation and integration...Medical device$21 - $33 per hour
...required to perform other related functions as assigned. Working Conditions: The work conditions are in a climate controlled medical device assembly room. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential...Medical devicePart timeWork experience placementLocal areaImmediate startFlexible hoursShift workWeekend work- ...Design the Electronics Behind Life-Changing Medical Devices Are you passionate about creating... ...EMI requirements, FCC, RED, or similar regulatory standards. Familiarity with embedded... .... At Medela, you will be joining a global community of colleagues, united by the...Medical deviceLocal areaWorldwide
$140k
...Medela Medizintechnik GmbH & Co. Handels KG in McHenry, IL, is seeking a Senior Product Manager for Medical Devices SaaS & Connectivity. This role involves leading the evolution of connected healthcare solutions in the NICU and maternity care space. The candidate will...Medical device- Medela Medizintechnik GmbH & Co. Handels KG is looking for a driven Associate Sales Representative to support its Maternal and NICU sales team across the East Coast territory. This role involves extensive travel (approximately 85%), where you'll build relationships with...Medical device
- ...preferred Minimum 2 years of quality engineering or quality systems experience in a manufacturing environment Experience with medical device and/or automotive quality systems preferred Auditor certification or auditing experience preferred Experience with wire...Medical deviceWork at office
- ...Description: Integration (Process Validation) Engineer Medical Device Contract Manufacturer – Flexible Films & Packaging... ...specific quality requirements. • Support internal, customer, and regulatory audits. Project Management & Customer Communication •...Medical deviceContract workFlexible hours
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