Remote Director of Regulatory Affairs - SaMD/Medical Devices
UnitedHealth-Grou
- Remote job
UnitedHealth Group is seeking a Director of Regulatory Affairs—Remote to lead regulatory activities for medical devices, including software and digital health technologies. You will shape strategies, advise on compliance, and drive submissions across global authorities from a remote setting. In this role, you will build and guide the regulatory team, collaborate with Legal and Compliance, and ensure policies align with evolving FDA, EU MDR, ISO 13485, and related standards. #J-18808-Ljbffr UnitedHealth-Grou
- A leading medical technology firm is seeking a Regulatory Affairs professional to develop and execute regulatory... ...for innovative medical devices. The ideal candidate... ...as a Medical Device (SaMD). This full-time position... ...match. This position is remote, allowing flexibility in...Remote workMedical deviceFull time
$134.6k - $230.8k
...,800/yearJob Area: Regulatory & ComplianceCompany... ...Growing together. The Director of Regulatory Affairs will be a member of... ...matters related to medical devices, including software... ...to work remotely * from anywhere within... ...devices (FDA, QSMR, SaMD, ISO 13485, ISO 149...Remote workMedical deviceMinimum wageFull timeWork experience placementWork at officeLocal area$127k - $165k
...Developing and executing regulatory strategies for new and modified medical devices in line with business... ...Software as a Medical Device (SaMD) productsKey Regulatory... ...and/or EU regulatory affairs experience with a... ...events and more!Location:Remote - USActual compensation...Remote workMedical deviceFull time- ...Developing and executing regulatory strategies for new and modified medical devices in line with business... ...Software as a Medical Device (SaMD) products Serving as... ...and/or EU regulatory affairs experience with a... ...events and more Location Remote – US EEO Statement iRhythm...Remote workMedical deviceFull time
$127k - $165k
...Developing and executing regulatory strategies for new and modified medical devices in line with business... ...Software as a Medical Device (SaMD) products Key... ...US and/or EU regulatory affairs experience with a... ...and more! Location Remote - US Estimated Pay Range...Remote workMedical deviceFull time- ...Regulatory Compliance Manager At Spacelabs Healthcare, we are on... ...patient data across local and remote systems, enable better-informed... ...guidance on applicable medical device regulations, standards, and quality... ...including active devices and SaMD). ~4+ years of post-market...Remote workMedical deviceWork at officeLocal areaWorldwide3 days per week
- ...Head Of Regulatory Affairs Remedy Robotics is a medical technology company developing robotic systems for endovascular... ...affairs experience in medical devices, including direct leadership of at... ...with Software as a Medical Device (SaMD) and AI/ML-enabled regulatory submissions...Remote workMedical device
- ...is seeking an experienced Director of Regulatory Affairs to provide strategic and operational... ..., biologic, and device programs. This position offers... ...clients in a fully remote, East Coast-based role. Key... ...pharmaceutical, biologics, and/or medical device sectors. In-depth...Remote workMedical deviceFull time
- ...proactive, experienced regulatory and quality leader to... ...on-site role (no remote) is critical to ensuring... ...-quality Class II medical devices to global markets. Key... ...level Seniority level Director Employment type Employment... ...of Regulatory Affairs jobs in Greater Orlando...Remote workMedical deviceContract work
$110k - $150k
...At Tempus, we are building a regulatory team that will adopt... ...approaches as we develop regulated medical devices and seek marketing authorization... .... Our Manager of Regulatory Affairs will work closely with our... ...develop testing plans #LI-remote$110,000-$150,000The expected...Remote workMedical deviceFull time$220k - $260k
The Senior Director, Global Trade Compliance is responsible for shaping... ...function and will be fully remote, reporting to the Vice... ...strategy, ensuring alignment with regulatory requirements, operational... ..., preferably within medical device, diagnostics, pharmaceutical...Remote workMedical deviceHourly payFull timeWork from homeWorldwideFlexible hours$116k - $174k
...preparing responses related to recalls.Monitor regulatory changes related to field actions and... ...5+ years of experience in the medical device or pharma industry, experience with product... ...state, or local laws.SummaryLocation: Northfield, Illinois; Remote, USType: Full timeRemote workMedical deviceMinimum wageFull timeWork at officeLocal areaWorldwide$135k - $190k
...change.This position reports to the Senior Director, Global Commercial Operations &... ...Organizational Transformationand will be fully remote. In this role, you will have the... ...commercial excellence within life sciences, medical devices, diagnostics, or adjacent regulated...Remote workMedical deviceFull timeContract workPart timeWork from homeFlexible hours$110.9k - $157.9k
...SummaryChurch & Dwight is seeking a Manager, Regulatory Affairs - Cosmetics (Global) to serve as the... ...: This role is performed on a remote basis. Occasional attendance at in-person... ...such as household consumer chemicals, medical devices, or dietary supplements.Experience working...Remote workMedical deviceFull time- ...strategic and experienced Manager, Regulatory Affairs Advertising & Promotion to... ...impact, all while working remotely. This role extends beyond... ...stakeholders including Medical Affairs, Legal, Commercial,... ...pharmaceutical, biotech, or medical device industry, with a strong...Remote workMedical deviceWork from home
- A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology. The role requires 8-10 years of experience in US and EU regulatory affairs and strong project management skills...Remote jobMedical deviceFull time
$238k - $374k
...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...robust regulatory strategies for medical devices and drug-device combination... ...hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMedical deviceMinimum wageTemporary workWork at officeLocal areaWorldwide$115k - $158k
A leading global pharmaceutical company is seeking a Manager for Regulatory Affairs in Aesthetic Medical Devices. This remote role requires expertise in product environmental compliance and collaboration with Regulatory Affairs to meet global standards. The ideal candidate...Remote workMedical device- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations... ...need a Bachelor’s degree, 5+ years of experience in medical device regulatory affairs, and strong leadership skills....Remote jobMedical device
$101k - $125k
...the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel... ...Years of Managerial experience ~5 Years or Human tissue or medical device manufacturing ~ Thorough understanding of FDA, QSR, cGMP,...Remote workMedical deviceTemporary workWork experience placementMonday to FridayFlexible hours- ...location. Our team of medical clinicians,... ...the world’s first remotely-operated, semi-autonomous... ...You’ll own the regulatory strategy and FDA-... ...Class III surgical device with the FDA. You... ...years in regulatory affairs at medical device... ...a‑Medical‑Device (SaMD) and AI/ML‑...Remote workMedical devicePermanent employment
$113.41k - $141.76k
...mission forward. As a global medical technology leader for nearly... ...for managing support of regulatory affairs systems used to support the... ...regulations pertinent to medical devices, biologics, drugs and... ...ExpectationsUp to 20%This is a fully remote position; however,...Remote workMedical deviceWork at officeFlexible hours- Director, Regulatory Affairs - Permanent - Remote Proclinical is seeking a (Senior) Director, Regulatory Affairs for an exciting MASH‑focused biotechnology... ...pharmaceutical, biopharmaceutical, biotechnology and medical device companies. #J-18808-Ljbffr Proclinical StaffingRemote workMedical devicePermanent employment
- ...Executive Director, Regulatory Affairs Castle Biosciences Inc. is growing, and we are looking to... ...headquarters in Friendswood, TX (Will consider remote candidates who can work from their... ...diagnostics laboratory and medical device manufacturer, the Executive Director...Remote workMedical deviceFull timeWork from homeHome officeWeekday work
$100k - $140k
...Join to apply for the Regulatory Affairs Manager role at Keystone Industries We are passionate... ...an office setting, potential for 1 day remote. Ideal Candidates: Ideal candidates will... ...and product listings for drugs, medical devices, and cosmetics where applicable. Works...Remote workMedical deviceWeekly payWork at officeFlexible hours- ...Regulatory Affairs ManagerThe Regulatory Affairs Manager supports BioWave'... ...MDR transition of legacy MDD devices, supporting preparation and... ...regulatory affairs experience in the medical device industry, including... ...office environment and/or remote work.Physical Demands : The...Remote workMedical deviceWork at office
$220k - $290k
...difference in people's lives. Our medical devices, software and related... ...conditions.Job SummaryThe Senior Director, Global Compliance... ...ensure consistency, fairness, regulatory defensibility, and compliance... ...position is filled. For fully remote positions, compensation will...Remote workMedical deviceMinimum wageOngoing contractFull timeLocal areaWorldwide$154.4k - $242.55k
...the delivery of global regulatory strategies to support... ...biomarkers, diagnostic tests, devices and digital health... ...the Global Regulatory Affairs (GRA) function in... ...Experience working with medical devices and/or... ...communicationLocation: Remote within the USTakeda Compensation...Remote workMedical deviceMinimum wageTemporary workLocal area- ...The Director of Regulatory Affairs will be based in San Diego, CA The role includes but is not limited... ...work experience, preferably within the Medical Device industry. Minimum 5 years of... ...Familiarity with software-controlled devices, SaMD, and Cybersecurity Ability to travel...Medical deviceWork experience placementWork at office
- BioIntelliSense seeks a Director of Operations to lead cross-functional... ...execution for Class II medical devices. You will coordinate... ...Quality, Supply Chain, R&D, and Regulatory activities in a regulated environment... ...Onsite to Golden, CO with a remote-friendly start‑up culture....Remote workMedical device
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