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
$50 - $67 per hour
...50.00/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... ...analytical documentation. Seniority level Mid‑Senior level...Remote workSeniorContract work$55.03 per hour
...Infosoft, Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50 to $55.03/HR... ...months Location: Irvine, CA/Remote (9 am to 6 pm PST time... ...products. Create regulatory submissions (exercising judgment to protect... ...Affairs Specialist, IVD California, United States...Remote workSeniorFull timeWork at office- ...mission as our next The Senior Regulatory Affairs Specialist. This role manages... ...and IVDR regulatory submissions. Interacts with... ...projects. This role is remote eligible for... ...medical devices and/or IVD products. Works... ...and approves U.S. (FDA) and/or global product...Remote workSeniorWork experience placementWork at officeWorldwideHome officeNight shift
$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to join its Medical Solutions Regulatory... ...on product development, regulatory submissions, and compliance activities. The ideal... ...multiple projects effectively. This is a remote position, and qualified candidates...Remote workSenior- ...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to support its Medical Solutions team. This remote role involves providing regulatory expertise for medical devices and managing submissions across various projects. The ideal candidate should have 2+ years...Remote workSenior
$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position requires regulatory expertise to support... ...new product development and regulatory submissions. Ideal candidates will have 2+ years of...Remote workSenior- ...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to support its Medical Solutions Regulatory Affairs team. This remote position will involve providing regulatory expertise... ...development projects and regulatory submissions. The ideal candidate will demonstrate a...Remote workSenior
- ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to join their Medical Solutions team. This remote role will provide regulatory expertise across a diverse... ...product development projects, leading submissions for global registrations, and collaborating...Remote workSenior
- ...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to support our Regulatory Affairs team... ...development projects and regulatory submissions as part of a collaborative team. With... ...compliance and strategic planning, this remote position requires a Bachelor’s...Remote workSenior
- ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to support the Medical Solutions Regulatory... ...portfolio of medical devices. This remote position involves managing... ...compliance across domestic and international submissions. The ideal candidate will hold a...Remote workSenior
$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist who will support the Medical Solutions Regulatory Affairs team... ...devices, overseeing product development, submissions, compliance tasks, and more. This remote position requires strong organizational and communication...Remote workSenior$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to support the Medical Solutions team by providing regulatory... ...across various medical devices. This remote position involves preparing regulatory submissions, collaborating on international strategies, and...Remote workSenior$80 - $100 per hour
...100.00/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- Biocartis is searching for a Senior Regulatory Affairs Specialist to develop regulatory... ...and global standards. This remote position requires a Bachelor... ...Affairs, preferably with IVD or software. Key responsibilities... ..., preparing regulatory submissions, and monitoring changing...Remote jobSenior
$100.04k - $127.4k
## Senior Regulatory Affairs SpecialistApplylocations: Punetime type: Full... ...Regulatory Affairs Specialist### Job Description**Senior Regulatory... ...chain etc.) to create submission contents.* Lead 510(k) submission... ...for this Office/Remote position.**How we work together...Remote workSeniorFull timeWork at officeWork visaRelocation package3 days per week$115.26k - $149.16k
...seeking an experienced professional for a Regulatory CMC role based in El Segundo, California... ...position involves preparing regulatory submissions, supporting lifecycle management, and... ...with a balanced approach of onsite and remote working days. Salary ranges from $115,26...Remote jobSeniorFlexible hours- 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
- Work at Home Mania is seeking a regulatory affairs professional to manage local regulatory and ethics submissions. This remote role focuses on aligning strategies within the biotechnology sector. The ideal candidate will have experience in regulatory submissions and a...Remote jobLocal areaWork from home
$106k - $170.2k
Senior Regulatory Affairs Specialist Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...in the Santa Clara office (no remote option). The role provides... ...regulatory documentation for submissions to European Notified Bodies, FDA, and other authorities, and...Remote workSeniorWork at officeLocal areaImmediate startFlexible hours- ...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
$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- BeiGene, Ltd. is looking for a Senior Associate to manage U.S. regulatory submissions including INDs, NDAs, and BLAs. The role requires excellent communication, organizational skills, and a proactive approach. Experienced professionals with a scientific background and...Senior
$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- Amgen SA is looking for a Regulatory Affairs Senior Associate to assist in creating and submitting regulatory documents essential for FDA compliance and submissions. The ideal candidate will support various regulatory activities, ensuring all documentation is accurately...Senior
- 6AM City, LLC is seeking a Regulatory Operations Contractor to support the development and implementation of systems for regulatory submission activities. This position offers fully remote work options and requires candidates to work during EST hours. Responsibilities include...Remote workContract workFor contractors
- Dormont Manufacturing Co is seeking a Regulatory Specialist to ensure timely regulatory submissions and maintain regulatory dossiers. This role requires collaboration with project teams and regulatory agencies. Applicants must have a Bachelor’s degree in a relevant scientific...Remote job
$75k - $85k
A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree... ...offers 2 days on-site and 3 days remote work. The salary ranges from $75,000...Remote workWork at office$115.5k - $156.4k
...Regulatory Affairs Representative Represents the Regulatory Affairs... ...technical documentation/submissions for regulatory approval in the... ...approximately 25% of the time for a remote arrangement. Travel may... ...team behind the world's first FDA approved, leadless left ventricular...Remote jobSeniorLocal areaFlexible hoursNight shift- Overview Regulatory Affairs Consultant - China (IVD / IUO / Software) Location: U.S.-based (remote) Engagement: Contract / Consulting (scope and duration TBD) We are supporting... ...planning for potential future NMPA submissions , as applicable Required Experience & Qualifications...Remote workContract work
$66.5k - $88.02k
...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The role involves ensuring... ...and communication skills. Additionally, this is a remote position with an anticipated salary range of $66,500 to $8...Remote workSenior
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