Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Remote Senior Regulatory Specialist - IVD FDA Submissions

Planet Pharma

California, MO
  • 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

Vacancy posted 16 hours ago
Similar jobs that could be interesting for youBased on the Remote Senior Regulatory Specialist - IVD FDA Submissions in California, MO vacancy
  • $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 work
    Senior
    Contract work

    Planet Pharma

    California, MO
    2 days ago
  • $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 work
    Senior
    Full time
    Work at office

    Infosoft Inc

    New York, NY
    16 hours ago
  •  ...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 work
    Senior
    Work experience placement
    Work at office
    Worldwide
    Home office
    Night shift

    QuidelOrtho

    Bakersfield, CA
    3 days ago
  • $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 work
    Senior

    Cardinal Health

    Cheyenne, WY
    16 hours ago
  •  ...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 work
    Senior

    Cardinal Health

    Helena, MT
    4 days ago
  • $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 work
    Senior

    Cardinal Health

    Phoenix, AZ
    16 hours ago
  •  ...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 work
    Senior

    Cardinal Health

    Topeka, KS
    4 days ago
  •  ...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 work
    Senior

    Cardinal Health

    Charleston, WV
    3 days ago
  •  ...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 work
    Senior

    Cardinal Health

    Carson City, NV
    1 day ago
  •  ...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 work
    Senior

    Cardinal Health

    Hartford, CT
    16 hours ago
  • $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 work
    Senior

    Cardinal Health

    Maryland
    2 days ago
  • $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 work
    Senior

    Cardinal Health

    Washington DC
    1 day ago
  • $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 work
    Senior
    Hourly pay
    Permanent employment
    Full time
    Contract work
    For contractors

    Connect Life Science

    California, MO
    2 days ago
  • 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 job
    Senior

    Biocartis

    New York, NY
    16 hours ago
  • $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 work
    Senior
    Full time
    Work at office
    Work visa
    Relocation package
    3 days per week

    Philips International

    Murrysville, PA
    16 hours ago
  • $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 job
    Senior
    Flexible hours

    Kite Pharma

    El Segundo, CA
    4 days ago
  • 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 work
    Senior
    Work at office

    Bioventus LLC

    Durham, NC
    2 days ago
  • 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 job
    Local area
    Work from home

    Work at Home Mania

    New York, NY
    1 day ago
  • $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 work
    Senior
    Work at office
    Local area
    Immediate start
    Flexible hours

    Johnson & Johnson

    Santa Clara, CA
    1 day ago
  •  ...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 work
    Senior
    Contract work
    For contractors
    Worldwide
    2 days per week

    BBG Ventures, LLC

    Sunnyvale, CA
    3 days ago
  • $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

    Abbott Laboratories

    Santa Clara, CA
    2 days ago
  • 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

    BeiGene, Ltd.

    New York, NY
    3 days ago
  • $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 work
    Senior
    Full time
    Local area
    Flexible hours

    Lexington Medical, Inc

    New York, NY
    16 hours ago
  • 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

    Amgen SA

    New York, NY
    4 days ago
  • 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 work
    Contract work
    For contractors

    6AM City, LLC

    Oklahoma City, OK
    4 days ago
  • 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

    Dormont Manufacturing Co

    Lake Zurich, IL
    1 day ago
  • $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 work
    Work at office

    Technical Resources International, Inc.

    Bethesda, MD
    1 day ago
  • $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 job
    Senior
    Local area
    Flexible hours
    Night shift

    EBR Systems, Inc.

    Sunnyvale, CA
    4 days ago
  • 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 work
    Contract work

    CSG Talent

    New York, NY
    16 hours ago
  • $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 work
    Senior

    Cardinal Health

    Juneau, AK
    16 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Remote Senior Regulatory Specialist - IVD FDA Submissions. Be the first to apply!