Regulatory Affairs Manager, Medical Devices (FDA/EU)
Katalyst CRO
A leading contract research organization in Austin, Texas is seeking a Mid-Senior Regulatory Affairs professional. You will oversee regulatory strategies for medical devices, manage submissions, and guide teams on compliance with FDA and EU regulations. Ideal candidates have 5+ years of experience, strong leadership skills, and a bachelor's degree in a relevant field. This contract role offers the opportunity to work within a dynamic environment focused on excellence and innovation. #J-18808-Ljbffr Katalyst CRO
- ...Solutions team. Develop regulatory strategies for... ...new, and modified medical devices and other regulated products. Manage and submit 510(k)s... ...and communicate with FDA, including pre-submissions... ...teams on US and EU regulatory... ...senior Regulatory Affairs professionals, including...Medical deviceContract workWork at office
- ...Regulatory Affairs Manager The primary job responsibility for this position is... ...existing, new, and modified medical devices and other (regulated)... ...manages communications with FDA including pre-subs. The individual... ...teams on US and EU regulatory requirements. This...Medical deviceWork at office
$85k - $95k
LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations, prepare regulatory... ...with various teams to ensure compliance with EU and FDA regulations. The ideal candidate will have experience in medical writing, specifically with Clinical...Medical deviceRemote job- ...II to provide design assurance and ensure compliance with FDA and ISO standards for robotic medical devices. The role involves collaborating with various engineering teams and supporting product risk management to enhance patient outcomes. Candidates should have a Bachelor...Medical device
- ...role. You will support QA activities across the manufacturing process, investigate issues, develop inspection methods, and help ensure FDA QSR and ISO 13485 compliance. Ideal candidates are recent graduates or early-career engineers with strong analytical skills, detail...Medical deviceFull time
- ...Vice President of Regulatory Affairs About the Company A pioneering medical device company developing first-in-class technologies for critical unmet clinical needs... ...in PMA submissions, IDEs, and complex FDA interactions, particularly for high-risk devices...Medical device
$80k
...Territory Manager - Austin Austin, TX Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep... ...are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce...Medical deviceWork experience placementLocal areaFlexible hoursNight shift$145k - $165k
...” Visit: Overview The Compliance Manager is a member of the FUJIFILM Holdings America... ...elements that support FUJIFILM’s Medical Device Compliance Program in line with OIG’s guidance... ...colleagues in Legal, IT, HR, Finance, Regulatory and other core functions in order to...Medical deviceRemote workFlexible hours- ...seeking an Assembly Technician in Austin, TX, to join a startup manufacturing team. The role involves assembling and inspecting medical device components using basic hand tools in a climate-controlled environment. You will contribute to a growing function, taking on...Medical device
- Enovis Corp is seeking a Senior Regulatory Affairs Specialist in Austin, TX to develop and... ...execute regulatory strategies for medical devices. This role is essential for managing product submissions and ensuring compliance with FDA, EU, and TGA regulations. The ideal candidate...Medical device
$71k - $119k
Neuralink is looking for a Regulatory Engineer in Austin, Texas, to join their Regulatory Team. This role involves managing regulatory affairs and ensuring compliance during product development and post-market phases. Candidates should have a Bachelor’s degree in engineering...Medical deviceFull time- ...Innovation Company Pty Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for medical devices in Austin, Texas. This position demands expertise in regulatory submissions across the US, EU, and Australia, combined with 7-8 years of...Medical device
- ..., and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745. The ideal applicant should possess... ...of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to...Medical device
- A medical device company located in Austin, Texas is seeking a Quality Management System specialist. This role involves ensuring compliance with medical device regulations... ...should have a strong background in regulatory requirements like ISO 13485, experience with...Medical device
- A leading medical device company in Austin is seeking an experienced Electrical Hardware Engineer to support R&D and manufacturing of innovative cancer treatment technologies. The ideal candidate will have a background in electrical engineering with over 7 years of experience...Medical deviceContract work
- ...electrical engineering, with skills in circuit design and test engineering. Key responsibilities include performing design activities and improving product quality. This on-site position offers a collaborative environment focused on medical devices. #J-18808-Ljbffr Cube Hub Inc.Medical device
- ...Austin, Texas is seeking a Quality Management System Specialist to ensure compliance with medical device regulations. This role... ...requires extensive knowledge of FDA regulations, ISO standards, and... ...years of experience in Quality/Regulatory Compliance. Strong...Medical device
- ...improvement. Ideal candidates have a degree in Engineering or a related field and experience in regulated manufacturing environments. The position offers generous benefits including 5 weeks paid time off and comprehensive medical coverage. #J-18808-Ljbffr Artivion, Inc.Medical device
$97k - $121k
...based in Austin, TX, is looking for a qualified Software as Medical Device (SaMD) Quality Engineer to oversee AI-enabled products. This... ...experience in medical device quality systems and compliance with regulatory standards. The position offers a competitive salary between $...Medical deviceFlexible hours$105k - $175.5k
Neuralink in Austin, TX seeks an Electrical Engineer for the Surgery & Robotics Hardware Team. This role focuses on designing and overseeing custom electronics systems that support cutting-edge healthcare technologies. The ideal candidate should have a Bachelor's in Electrical...Medical device- A leading medical equipment manufacturer is seeking a Senior Manufacturing Engineer to support site transfers and product launches. This role requires a minimum of 4 years of experience in medical device manufacturing, along with strong knowledge of process validation and...Medical deviceContract work
- A technology firm in Austin seeks a Senior Electrical Engineer for a contract role focused on medical device manufacturing. The ideal candidate will have over 7 years of experience, a strong electrical design background, and skills in test engineering. Responsibilities...Medical deviceContract workFlexible hours
- DiaSorin is seeking a Manufacturing Engineer, Level II, located in Austin, Texas. This role involves designing and implementing automated control systems for enhancing manufacturing efficiency and reliability. Ideal candidates will have a Bachelor's degree in engineering...Medical device
- ...BSI notified body audit. Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745. Conduct rigorous onsite... ..., specifically in Quality Assurance or Regulatory Affairs. Certified ISO 13485 Lead Auditor (IRCA...Medical deviceImmediate start
- ...Austin, TX, to provide expert technical support and manage multiple projects related to manufacturing and regulatory compliance. The ideal candidate should have a... ...to ensure project success. Knowledge in medical devices and project management experience are highly desired...Medical device
- ...product development in Austin, Texas. The role involves ensuring compliance with quality systems and regulatory standards, as well as leading audits and analyses of device failures. Candidates must have a Bachelor’s degree in Biomedical or Mechanical Engineering and 5+...Medical deviceWork at office
- ...implementation of the Quality Management System (QMS). The... ...compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate... ...knowledge of global regulatory requirements for medical...Medical deviceLocal area
- A leading neural technology company is seeking a Manufacturing Engineer to scale the production of surgical consumables in Austin, Texas. The role involves hands-on troubleshooting, data analysis, and design of manufacturing processes to ensure high-quality production. ...Medical deviceFlexible hours
- ...pharmaceutical, biotech, and medical device industries with our proven,... ...approach to complex trial data and regulatory submission challenges. With... ...and drug supply management teams. Develop phase 1-4... ...to understand guidance from FDA from the different therapeutical...Medical deviceRemote work
$43.33 - $52.12 per hour
...in Austin, TX a medical tech leader redefining... ...and global regulatory knowledge to a... ...of the Quality Management System (QMS).... ...compliance with medical device regulations, including FDA 21 CFR Part 820, ISO 13485, and EU MDR. Partner... ...Regulatory Affairs / Compliance...Medical deviceHourly payContract workTemporary workWork experience placementLocal area
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