Senior Regulatory Affairs Lead - SaMD/MedTech (Remote)
OrganOx Limited
Madison, NJ
- Remote job
OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards. The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of #J-18808-Ljbffr OrganOx Limited
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead - SaMD/MedTech (Remote) in Madison, NJ vacancy
- ...company focused on organ technology. The Senior Regulatory Affairs Specialist will lead regulatory submissions for North... ...products. The role is flexible remote or hybrid on-site in Madison, NJ with... ...for Class II/III devices and SaMD/SiMD. #J-18808-Ljbffr OrganOx LimitedRemote jobSeniorFlexible hours
- Innolitics LLC is a remote-first medical device consultancy hiring a Senior Regulatory Affairs Specialist to lead regulatory engagements for AI/ML-enabled SaMD. You will shape regulatory strategy, advise on FDA AI/ML framework, and drive Fast 510(k) sprints to completion...Remote jobSenior
$160k - $170k
Fresenius Kabi seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making and strategy for complex product lines, regions, or topics.... ...Zurich, IL requires 3 days per week in the office with some remote work and does not sponsor visas. Responsibilities...Remote workSeniorWork at officeVisa sponsorship3 days per week- ...expertise in Innovative Medicine and MedTech, we are uniquely positioned to... ...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... ...searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation &...SeniorFull timeWork at officeLocal areaImmediate startRelocation packageFlexible hours3 days per week
$109k - $174.8k
...Innovative Medicine and MedTech, we are uniquely positioned... ...merit. Job Function Regulatory Affairs Group Job Sub Function... ...United States of America, Remote (US), Santa Clara,... ...for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation...Remote workSeniorLocal areaImmediate start- Jobtailor in the United States is seeking a Senior Regulatory Affairs professional to develop and maintain regulatory frameworks for SaMD and AI/ML-enabled products. You will partner with engineering, product, and quality teams to operationalize regulatory requirements...Senior
- A pioneering MedTech company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior...Senior
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories team within the OTTAVA robotics group. The role focuses on achieving US and international regulatory approvals for robotics, instruments and accessories...Remote jobSenior
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workSeniorLexington Medical, Inc.
United States1 day ago- Advita Ortho in the US (Remote) seeks a Sr Manager, Regulatory Affairs to provide strategic leadership for the postmarket regulatory team, directing regulatory strategies, submissions and ongoing compliance for commercialized orthopaedic products. You will collaborate...Remote jobSenior
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote jobSenior
- Jobtailor is seeking an experienced Regulatory Affairs professional in the United States to drive regulatory strategy for new medical device... ...communication, and project management skills. Advanced degrees are a plus; remote work options may vary. #J-18808-Ljbffr JobtailorRemote workSenior
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization... ...environment, and strong communication skills. This position is remote and requires some travel. Competitive salary and benefits...Remote jobSenior
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercialization. The role leads global CMC strategies, drives submissions, and partners with Regulatory, Operations...Remote jobSenior
$120k - $200k
A leading life sciences technology company is looking for a Senior Product Manager to define and deliver the MedTech strategy. Ideal candidates will have significant experience in MedTech product management or commercial operations. Responsibilities include influencing...Remote jobSeniorFlexible hours$212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...understanding broad concepts within regulatory affairs and implications across the... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workSeniorMinimum wageTemporary workLocal areaWorldwide$110k - $135k
Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory... ...life sciences and diagnostics. You will lead the creation of regulatory documents and... ...vitro diagnostics. This position is fully remote, offers a salary range of $110,000 - $1...Remote jobSenior$169.5k - $248.6k
...to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...and 8+ years of experience in regulatory affairs and/or drug developmentORBachelor’s or... ...Indianapolis, IN and relocation is provided, remote is not available for this role....Remote workSeniorLocal areaRelocationFlexible hours- Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our... ...balance AI-enabled tools with regulatory rigor, partnering with Regulatory Affairs, Clinical Development, Biostatistics... ...audit-ready submissions. You will lead CRO relationships, set standards,...Remote jobSenior
$258.68k - $313.46k
...us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...impact BMS, regulatory affairs or projects and provides... ...centers. Employees in remote-by-design or lab-based... ...with Ripley.R1603594 : Senior Director, Global Regulatory...Remote workSeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...A leading medical device company in Austin, TX seeks a Senior Regulatory Affairs Specialist to develop regulatory strategies and manage product submissions for innovative technologies within the orthopedic space. The candidate will work on medical devices that leverage...Senior
Enovis
Austin, TX2 days ago - 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 jobFull time
- 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 jobFull time
$80k - $200k
...experienced consultant to lead MedTech Regulatory Information... ...customers’ Regulatory Affairs and Operations processes... ...as a Medical Device (SaMD) or combination productsExperience... ...with our group's Senior Leader.Once all... .../or stock bonus.#LI-Remote#LI-MidSeniorVeeva’s...Remote workSeniorWork at officeLocal areaWork from home3 days per week- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories portfolio within the OTTAVA robotics group. You will help US and international regulatory submissions and interact with health authorities, engineering...Remote jobSenior
$82.92k - $150k
...A leading cryptocurrency exchange is seeking a Senior Compliance Officer to develop and implement compliance programs related... ...$82,921 to $150,000 and is fully remote, providing flexibility in a dynamic environment focused on regulatory compliance and risk mitigation. #J-...Remote workSeniorTOP cryptocurrency exchange
United States2 days ago- Ensemble Health Partners seeks a Senior Coding Compliance Auditor to lead the development and execution of the annual compliance workplan, including auditing and monitoring workplans, and to deliver detailed audits and high-quality reports. The role involves coaching auditors...Remote jobSenior
- Emory University is seeking a Senior Research Compliance Specialist to ensure adherence to federal, state, sponsor, and university regulations... ...of responsible research conduct. Additionally, the specialist leads export control efforts and provides training on compliance...Remote jobSenior
- Tailored Brands, Inc. is seeking a Senior Customs Compliance Manager based in Dublin, CA. This role involves leading the customs compliance program for U.S. imports and requires extensive knowledge of customs regulations. Candidates should have over 8 years of relevant...Remote jobSenior
- JFF in Washington, DC area seeks a Senior Payroll Accountant to lead core payroll and payroll-accounting functions, partnering with a third-party provider to ensure timely, accurate payroll execution. The role covers reconciliations, month-end close, audit prep, financial...Remote jobSenior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - SaMD/MedTech (Remote). Be the first to apply!
Related searches
- senior application security Madison, NJ
- senior Madison, NJ
- senior operations technician Madison, NJ
- senior brand designer Madison, NJ
- international tax senior Madison, NJ
- senior software engineer remote Madison, NJ
- senior performance engineer Madison, NJ
- senior litigation attorney Madison, NJ
- senior activities Madison, NJ
- senior manager legal Madison, NJ