Remote Senior Regulatory Specialist - IVD FDA Submissions
Planet Pharma
- Remote job
A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory affairs, particularly in IVD product development. The specialist will collaborate with R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication skills are essential. Enjoy competitive compensation and flexible work arrangements. #J-18808-Ljbffr Planet Pharma
$117.77k - $161.93k
...their career. This is a remote role. As a Senior Regulatory Affairs Specialist, you will be responsible... ...and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes... ...of point-of-care IVD products and applicable...Remote workSeniorTemporary workWork at officeLocal area- 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...Remote jobSenior
$55.03 per hour
...Infosoft, Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50 to $55.03... ...Location: Irvine, CA/Remote (9 am to 6 pm PST time zone... .... Create regulatory submissions (exercising judgment to protect... ...Affairs Specialist, IVD California, United States...Remote workSeniorFull timeWork at office$50 - $67 per hour
...0.00/hr - $67.00/hr Sr. Regulatory Specialist Fully remote in PST time zone ONLY Do... ...is a key contributor to FDA submissions (PMA/510(k)) and requires... ...scientific writing, knowledge of IVD product development... ...documentation. Seniority level Mid‑Senior level Employment...Remote workSeniorContract work$120k - $160k
Senior Regulatory Affairs Specialist Location: Remote (U.S. only, excluding Alaska and Hawaii) Job Type: Full-time About... ...reach market, including 50+ FDA clearances. Learn how we take devices... ...AI/ML framework, and drive submissions to completion. You'll lead Fast 5...Remote workSeniorFull timeFlexible hours- ...Instagram , X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact,... ...work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie North Chicago, IL headquarters....Remote workSeniorFull timeTemporary workWork at officeLocal area
- Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate...SeniorFlexible hours
- ...Supporting regulatory strategy and operations for the Software... ..., the full-time remote Senior Regulatory Affairs Specialist will manage regulatory activities... ...lifecycle, including submissions, document management,... ...SaMD Familiarity with FDA medical device requirements...Remote workSeniorFull time
$99k - $129k
...Senior Regulatory Affairs Specialist At iRhythm, you'll have the opportunity to grow your skills and your... ...and better healthcare. As a remote Senior Regulatory Affairs Specialist... ...project teams from preparation to submission and through successful dossier reviews...Remote workSeniorFull time- ...Senior Regulatory Affairs Specialist Working at Yale means contributing to a better tomorrow. Whether you... ...trials, overseeing study start-up, submissions, maintenance, and ongoing compliance... ...knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice...Remote workSeniorInterim roleWork at officeLocal area
- iRhythm Technologies, Inc. is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for medical devices and SaMD. This remote US role partners with cross-functional teams to prepare submissions, align labeling, and navigate regulatory approvals...Remote jobSenior
- ...device company focused on organ technology. The Senior Regulatory Affairs Specialist will lead regulatory submissions for North America, support ISO/GMP compliance, and... ...advance OrganOx products. The role is flexible remote or hybrid on-site in Madison, NJ with up to 5%...Remote jobSeniorFlexible hours
$150k - $185k
...Senior Specialist, Clinical Regulatory Affairs This role supports end-to-end planning and delivery of global clinical submissions, assists with the creation and release of core regulatory dossier... ...regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.)....Remote workSeniorLocal area$140k - $160k
...Senior Regulatory Affairs Specialist Iovance Biotherapeutics aims to be the global leader... ...regulatory authority submissions. They will independently with... ...of briefing packages for FDA meetings, and support the... ...engage in both in-person and remote team members. Excellent...Remote workSeniorWork at office- ...We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy... ...product lifecycle, including submission support, document management... ...standards, such as: ~ FDA medical device requirements... ...recruiters, especially for remote roles. Please note:...Remote workSeniorWork at officeLocal areaFlexible hours
- ...Senior Regulatory Affairs Specialist Give hope. Give health. Make your mark in the fight against cancer... ...Pacific region. The work location is remote based on the supported markets.... ...regional regulatory strategies and submission plans aligned to business objectives...Remote workSeniorPermanent employment
- ...supplements, IDEs, and/or 510(k) submissions Owning regulatory strategy for product... ...submissions Strong knowledge of FDA regulations (21 CFR 820, 81... ..., MA Some flexibility for remote work on Fridays Occasional... ...currently operating at a Senior level and ready for greater...Remote workSenior
- Position Senior Regulatory Affairs Specialist - Durham, NC - Bioventus LLC. Responsibilities... ...regarding product submissions, changes (manufacturing, design... ...following agencies or regions: FDA, EMEA, Canada, LATAM,... ...days in office and 2 days remote within commuting distance....Remote workSeniorWork at office
$80 - $100 per hour
...00.00/hr Quality, Regulatory & R&D Staffing Expert... ...business to hire a Senior Regulatory Affairs Specialist (Contractor). This... ...to complete first submissions and filings in 2026... ...full‑time) Location: Remote with some travel to... ...submissions to FDA Collaborating with...Remote workSeniorHourly payPermanent employmentFull timeContract workFor contractors- ...Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, INDs,... .... This is a flexible Remote or hybrid on-siteposition in... ...etc.) for submission to the FDA and Health Canada. Interfacing...Remote workSeniorFor subcontractorFlexible hours
- Avetix Bio is seeking a Senior Specialist, Regulatory Affairs to lead regulatory compliance strategies and... ...the team, preparing CTDs, managing submissions, and maintaining ongoing compliance for... ...products, with strong emphasis on FDA/ICH guidelines and timely responses to...Senior
- ...healthcare challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on‑site, 2 days remote per week) located in Sunnyvale, CA.... ...lead regulatory documentation and submissions, including FDA 510(k) pre‑market notifications, Letters...Remote workSeniorContract workFor contractorsWorldwide2 days per week
$92k - $148.35k
...merit. Job Function Regulatory Affairs Group Job... ...States of America, Remote (US), Santa Clara, California... ...best talent for a Senior Regulatory Affairs Specialist to support our... ...stages and generating submission ready documentation... ...writing and filing of FDA submissions...Remote workSeniorLocal areaImmediate start- Neurocrine Biosciences is seeking an experienced Regulatory Submissions Specialist to coordinate preparation of submissions to regulatory authorities,... ...including INDs and annual reports. You will ensure alignment with FDA, ICH guidelines and internal policies while maintaining...Senior
$90k - $180k
Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist at their Santa Clara, CA location. This role involves supporting the regulatory... ...regulatory input for product lifecycles and handling submissions to regulatory authorities. The ideal candidate should have...Senior- Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for development, sustaining engineering, and acquisition... ...You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure...SeniorWork at office3 days per week
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The... ...with cross-functional teams. This mid-senior position focuses on ensuring timely, compliant...SeniorFull time
$115k - $185k
Senior Regulatory Affairs Specialist (Senior IC or Manager) Lexington Medical, Inc. is hiring... ...global medical device submissions and regulatory strategy. For... ...area, this role can be remote with expectations to work... ..., and guidance, including FDA requirements, EU MDR, MDSAP...Remote workSeniorFull timeLocal areaFlexible hours- Calyxo, Inc. in Pleasanton, CA, seeks a Senior Regulatory Affairs Specialist to independently manage US and international regulatory filings for category... ...balancing speed with compliance. The ideal candidate has FDA experience, strong technical writing skills, and...Senior
- West Pharmaceutical Services, Inc. is seeking a Senior Specialist, Regulatory Operations to publish, format, and maintain regulatory documentation... ...with cross-functional teams to ensure compliant submissions on schedule. The role emphasizes high-quality execution,...Senior
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