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
- UnitedHealth Group is seeking a Director of Regulatory Affairs to lead strategic regulatory counsel for medical devices, software, and digital health products. You will shape enterprise regulatory programs, collaborate with legal, compliance, and business teams, and drive...Remote jobMedical device
- 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
- ...seeking a full-time Senior Manager, Regulatory Affairs to lead regulatory excellence in their medical imaging portfolio. This role... ...lifecycle while working remotely. The ideal candidate will have... ...expertise with Software as a Medical Device (SaMD) and a proven ability to lead...Remote jobMedical deviceFull time
$134.6k - $230.8k
Director of Regulatory Affairs - Remote UnitedHealth Group is a healthcare and well‑being company that’s dedicated... ...and quality matters related to medical devices, including software and algorithms... ...for medical devices (FDA, QSMR, SaMD, ISO 13485, ISO 14971, IEC 62304,...Remote jobMedical deviceFull timeWork experience placementWork at officeLocal area- ...is seeking an experienced Director of Regulatory Affairs to provide strategic and operational... ..., biologic, and device programs. This position offers... ...external clients in a fully remote, East Coast–based role. Key... ..., biologics, and/or medical device sectors. In-depth knowledge...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 Bachelor... ...– $165,000.00 Location Remote – US As a part of our...Remote workMedical deviceFull time$125k - $150k
...physicians we serve. POSITION SUMMARY Lead regulatory activities including 510(k), pre-... ...). 3–5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment.... ...options to choose from. Flexible Remote Schedules. Nashville, TN preferred...Remote workMedical deviceWork experience placementFlexible hours- ...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
- ...Director, Regulatory Affairs — ImBed Biosciences Location: Madison, WI (on-site, hybrid, or remote) About ImBed Biosciences ImBed Biosciences is a medical technology company advancing novel biomaterials that... ...registrations, listings, and device listings; manage UDI/GUDID...Remote workMedical device
- ...patient data across local and remote systems, enable better-... ...environment for patients. The Regulatory Compliance Manager is responsible... ...provide guidance on applicable medical device regulations, standards, and... ...including active devices and SaMD). 4+ years of post‑market surveillance...Remote workMedical deviceWork at officeLocal area3 days per week
- Radiology Partners seeks a Regulatory Affairs Leader to drive FDA submissions, 510(k) planning, and De Novo strategies across medical devices and SaMD. You will manage the eQMS program, CAPA, and design history files, partnering with Engineering, Legal, and executives to...Remote jobMedical device
- ...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
- ...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
$130 - $140 per hour
Director of Regulatory Affairs, Business Excellence 1 week ago Be among the first 25 applicants This range... ...year Location: Redwood City, CA - Remote Role Job Summary The Director of... ...Sciences, Pharmaceutical Industry, Medical Device Industry, Regulatory Compliance, FDA...Remote workMedical deviceContract work$155k - $185k
WHOOP is seeking a Senior Program Manager, SaMD, located in Boston, MA. This role involves driving execution of Software as a Medical Device programs, collaborating with various teams to ensure regulatory compliance and successful product delivery. Candidates should have...Medical device$145k - $165k
...a Juris Doctor degree and strong compliance experience in the medical device industry. Responsibilities include implementing compliance frameworks... .... The role offers a competitive salary of $145,000 - $165,000 with additional benefits. Remote work is possible. #J-18808-LjbffrRemote workMedical device- A leading healthcare company is seeking a Manager of Regulatory Affairs based in remote locations. You will develop and execute regulatory strategies... ...FDA submissions, and ensure compliance for innovative medical devices. The ideal candidate has over 8 years of regulatory...Remote jobMedical deviceFull time
$145k - $165k
A leading medical device company is seeking a Compliance Manager to manage compliance operations and ensure adherence to healthcare regulations... .... This role offers a salary range of $145,000 - $165,000 depending on experience and the ability to work remotely. #J-18808-LjbffrRemote workMedical device- El Camino Health is looking for a regulatory affairs professional to develop and execute strategies for medical devices. This full-time remote position requires 8-10 years of regulatory experience, including authorship of 510(k)s and FDA submissions. The ideal candidate...Remote jobMedical deviceFull time
- ...Partners is seeking a Sr Manager for Regulatory Affairs to lead regulatory compliance in medical imaging solutions. This pivotal... ...years of experience in medical device regulatory affairs and strong... ...capabilities. The position offers a remote-first culture and comprehensive...Remote jobMedical device
- ...a seasoned professional to lead regulatory strategy for their medical imaging solutions. This role involves... ...0 years of experience in medical device regulatory affairs and a Bachelor's degree in a... ...certification. This position offers a remote-first work culture and...Remote jobMedical device
- 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
- ...support Quality Management System processes and ensure regulatory readiness. This remote role involves managing internal audits, CAPA processes,... ...related field and at least 4 years of experience in the medical device industry, with a strong focus on regulatory compliance....Remote jobMedical device
- A leading global medical device company seeks a Sr. Director, Compliance in California to oversee its healthcare compliance program. The role includes managing regulatory adherence, supporting business growth, and ensuring high standards of ethics and accountability. The...Remote jobMedical device
$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
- ...Job Description Job Description Remote Position for MST Time zone We're looking... ...development of a software-based medical device (SaMD). The ideal candidate has a solid foundation... ...documentation and ensuring continued regulatory alignment as the product moves...Remote jobMedical device
$100k - $130k
...Placement CornerStone Professional Placement is seeking a Regulatory Affairs Manager for a medical device manufacturing client in the Frisco, TX area. As the... ...Life Manager, Hospital Regulatory & Accreditation (Remote based in US) Regulatory Compliance Manager - Food...Remote workMedical deviceFull timeMonday to Friday- 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
$154k - $165k
...products as well as other consumable medical devices under a strong portfolio of world class... ...its products. This position can be a remote working arrangement. Candidates must... ...primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions...Remote workMedical deviceWork at officeLocal areaWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Director of Regulatory Affairs - SaMD/Medical Devices. Be the first to apply!
- excel remote Eden Prairie, MN
- marketing intern remote Eden Prairie, MN
- remote contract attorney Eden Prairie, MN
- clinical data manager remote Eden Prairie, MN
- entry level project manager remote Eden Prairie, MN
- physician consultant remote Eden Prairie, MN
- remote finance internship Eden Prairie, MN
- remote engineering internship Eden Prairie, MN
- grant writer remote Eden Prairie, MN
- remote medical data entry Eden Prairie, MN

