Regulatory Affairs Lead - Medical Devices & IVD (Remote)
QuidelOrtho
- Remote job
QuidelOrtho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics and medical devices in worldwide markets. You will manage U.S. submissions, interact with FDA and global agencies, and ensure compliance with QSR, ISO, CMDR, IVDR, and CFR requirements. This role is remote eligible. The position requires leadership, cross‑functional collaboration, and the ability to work independently on high visibility projects across regulatory disciplines. #J-18808-Ljbffr QuidelOrtho
- ...is seeking an experienced Senior Regulatory Affairs Manager to advance regulatory activities... ...for new in vitro diagnostics and medical devices worldwide. You will lead U.S. submissions, interact with... ..., and related regulations. This remote-eligible role supports U.S.-based...Remote jobMedical deviceWorldwide
- ...sciences company is seeking a Regulatory Affairs Consultant to provide... ...China-specific requirements for IVD and software-driven products... ...affairs, particularly within medical devices, and direct experience with... ...this position, which offers a remote working arrangement. #J-1880...Remote jobMedical device
- BD in Franklin Lakes, NJ, is seeking a Staff Regulatory Affairs Specialist to lead regulatory oversight of promotional materials for Specimen... ...days per week at the Franklin Lakes, NJ location, offering exposure to both medical devices and IVD regulatory #J-18808-Ljbffr BDMedical deviceWork at office
$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 workMedical device- Overview Regulatory Affairs Consultant - China (IVD / IUO / Software) Location: U.S.-based (remote) Engagement: Contract / Consulting (scope and duration TBD) We are supporting... ...of Regulatory Affairs experience within medical devices, diagnostics, or software-driven products...Remote workMedical deviceContract work
- VB Spine, a leading privately held spine company, is seeking a Sr. Staff Regulatory Affairs Specialist to drive global regulatory strategies for complex medical devices. This role partners with cross-functional teams to support development, lifecycle management, and submissions...Remote jobMedical 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
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in... ...The role requires advanced knowledge of medical device regulations, strong communication, and up to 25% travel. Remote options may be considered case-by-case....Remote workMedical 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
- MiniMed seeks a Regulatory Affairs professional to craft global clinical regulatory strategies for next-generation diabetes devices, including FDA submissions and EU MDR compliance. You will... ...submissions, with full remote work #J-18808-Ljbffr USA-Medtronic...Remote jobMedical device
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotic instruments and accessories. You will partner with engineering and clinical teams, develop submission-ready documentation, and guide global regulatory...Remote jobMedical device
- 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 jobMedical device
- ...their merit.Job Function: Regulatory Affairs GroupJob Sub Function:... ...States of America, Remote (US), Santa Clara,... ...Regulatory Affairs Program Lead to support our... ...feedback for specifications, device testing, risk... ...Affairs experience within Medical Device is required (4+...Remote workMedical deviceFull timeLocal areaImmediate start
- MiniMed is seeking a Regulatory Affairs professional to shape global clinical regulatory strategies for next‑generation diabetes devices, reimbursement, and post‑market surveillance. You will partner with clinical, medical affairs, and engineering in a matrixed environment...Remote jobMedical device
- ...Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for... ...SiMD and electromechanical devices. The role requires collaborating... ...with ISO, GMP, and medical device standards. The position offers flexible remote or hybrid on-site work in Madison...Remote jobMedical deviceFlexible hours
- ...Global Regulatory Affairs Lead Strivector Corp is a National Recruiting and Staffing agency established... ..., and compliance activities for medical device products. This role will ensure... ...benefits Location: Covington, Georgia Remote / Hybrid: On-site (4 days per week, Fridays...Remote workMedical devicePermanent employmentFull timeFor contractorsRelocation
$170k - $185k
QuidelOrtho is seeking a Senior Regulatory Affairs Manager to lead regulatory activities for new in vitro diagnostics and medical devices, managing US FDA submissions and global registrations... ...regulatory agencies. The position is remote eligible for candidates in the United...Remote workMedical device$109k - $174.8k
...Information Job Function: Regulatory Affairs Group Job Sub Function... ...States of America, Remote (US), Santa Clara,... ...Regulatory Affairs Program Lead to support our... ...feedback for specifications, device testing, risk... .... Has experience with medical device software guidance...Remote workMedical deviceLocal areaImmediate start- Advita Ortho is seeking a Sr Manager, Regulatory Affairs to lead the lifecycle regulatory activities... ...requires a strong background in medical device regulations, 10+ years of experience... ...influence cross-functional partners. Remote work option in the US is available....Remote jobMedical device
$320k - $380k
...difference in people's lives. Our medical devices, software and related... ...President, Chief Compliance Lead (CCL), Americas ensures ethical... ...state and federal laws and regulatory requirements.Drive a culture... ...is filled. For fully remote positions, compensation will...Remote workMedical deviceMinimum wageOngoing contractFull timeLocal areaWorldwide- ...Operations Leader in a Hospital, ASC and/or a Medical Device company ● Healthcare Native or Adjacent:... ...context. ●Call center operations or remote field support exposure (especially with... ...). ●Familiarity with vendor workflows. ●Leading ops inside organizations that scaled...Remote jobMedical deviceFull time
- Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate with...Remote jobMedical device
- ...To support regulatory compliance efforts, the full-time Regulatory Affairs Associate will prepare IVD regulatory documents for submission to... ...regulatory agencies while working remotely within the U.S. Key... ..., preferably in Medical Devices or IVDs Proven ability to...Remote workMedical deviceFull time
- Lead Strategic Sourcing Business Analyst CONMED is seeking a highly motivated and analytical... ...actionable insights. This is a remote role with 20% travel. Responsibilities Data... ...g., CPSM, PMP, CSCP). Experience in the medical device, healthcare, or manufacturing industries...Remote workMedical deviceWork experience placementImmediate start
$160k - $180k
...Compliance Lead Columbus, Ohio; Irvine, California; or Remote within the U.S. About Aegis Ventures... ...previously impossible medical challenges, bringing... ...biopharma research, medical device innovation, AI model... ...program turning our regulatory obligations into a scalable...Remote workMedical device- ...Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and... ...interface for FDA inspections, regulatory meetings, and... ...with Quality, Regulatory Affairs, Manufacturing, Engineering... ...industries such as Pharma, Medical Devices, Biotechnology, or...Remote workMedical device
$130k - $145k
...possible. The Program Manager, Medical & Scientific Affairs is responsible for delivering... ...team and will be fully remote.In this role, you will have the opportunity to:Lead key projects and cross functional... ...knowledge of in vitro diagnostics (IVDs).Understanding of product...Remote workMedical deviceFull timeWork from homeFlexible hours$110k - $150k
...we are building a regulatory team that will adopt... ...develop regulated medical devices and seek marketing... ...of Regulatory Affairs will work closely... ...Responsibilities Developing and leading global regulatory... ...like:Oncology IVD, IUO, and CDx... ...testing plans #LI-remote$110,000-$150,000...Remote workMedical deviceFull time$110k - $135k
...everything possible. The Principal Regulatory Affairs Specialist is responsible... ...of new and modified IVD medical devices and software while acting as... ...Boulder, COand will be fully remote. In this role, you will... ...opportunity to: Author and lead the creation of regulatory...Remote workMedical deviceFull timeLocal areaWork from homeFlexible hours$95.7k - $159.5k
...Stryker is hiring a Lead Analyst, Clinical Data Sciences... .... This is a U.S.-based remote position, with preference... ...helping stakeholders across Medical Affairs, Clinical Research, Regulatory Affairs, Reimbursement,... ...Familiarity with medical device regulatory requirements,...Remote workMedical deviceFull time
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