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

Regulatory Affairs Specialist

FUJIFILM Corporation

FUJIFILM Healthcare Americas Corporation is seeking an Regulatory Affairs professional to support U.S. FDA medical device regulatory compliance, ISO 13485 standards, and related regulations.

You will manage device marketing authorizations, EU MDR responsibilities, and European/International submissions while coordinating with multiple business units. The role requires hands-on regulatory experience in FDA-regulated environments, strong communication, and organizational skills.

#J-18808-Ljbffr
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in United States vacancy
  • The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and... 
    Suggested

    Cedent Consulting

    Plano, TX
    1 day ago
  • Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with... 
    Suggested

    Katalyst Healthcares & Life Sciences

    Minneapolis, MN
    2 days ago
  • The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance... 
    Suggested

    Cedent Consulting

    Addison, TX
    1 day ago
  •  ...both internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical...  ...Master s Degree a plus• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or... 
    Suggested
    Work at office
    Local area
    Immediate start

    Artech

    Bridgewater, NJ
    1 day ago
  • $107.2k - $160.8k

     ...font-size: 30px; font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and... 
    Suggested
    Work at office
    Local area
    Immediate start
    Flexible hours

    Coloplast

    Minneapolis, MN
    4 days ago
  •  ...approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs, for... 
    Work experience placement

    City of Hope

    Duarte, CA
    2 days ago
  •  ...is working in the CMC area. Relevant experience is requiredExperience: 3 to 6 yearsExperience with drug/biologics licensurePrior regulatory experienceTechnical writing experience (CMC experience )Scientific background,Required Skills:CMC/ Regulatory writing experienceScientific... 
    Work at office
    Immediate start

    Artech

    Swiftwater, PA
    1 day ago
  • Job-ID31525652Reference25-04486 ​​​​​ Responsibilities: The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality... 

    Katalyst Healthcares & Life Sciences

    Charlotte, NC
    1 day ago
  •  ...financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual... 
    Work at office
    Immediate start

    Artech

    Bridgewater, NJ
    3 days ago
  •  ...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic...  ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation... 
    Work at office

    Katalyst Healthcares & Life Sciences

    Tampa, FL
    1 day ago
  •  ...execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the... 
    Immediate start

    Artech

    Cambridge, MA
    1 day ago
  •  ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the...  ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    1 day ago
  • The Compliance Specialist reports to the Director Legal, Compliance, Privacy & Security (“Director”) and has a key role in supporting the...  ...basis.Conduct research and develop written communication on regulatory requirements to ensure ongoing updates upon request. Manage compliance... 
    Contract work

    Cedent Consulting

    Houston, TX
    1 day ago
  •  ...Description: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S...  ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems... 
    Work at office

    Katalyst Healthcares & Life Sciences

    Boulder, CO
    4 days ago
  • Brecksville, OHDescriptionJob Title: Regulatory Affairs SpecialistDepartment: RegulatoryReports To: Director of Regulatory AffairsFLSA Status: ExemptSupervise the work of others: NoPosition Summary:This position is responsible for preparing submissions to various regulatory... 
    Work experience placement
    Work at office

    Applied Medical Technology

    Brecksville, OH
    14 hours ago
  • $120k - $160k

     ...members to perform at a higher level through a deep understanding of their bodies and daily lives.WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health team.As the Regulatory Affairs Specialist II, Expansion, you... 
    Full time
    Work at office
    Relocation

    WHOOP

    Boston, MA
    4 days ago
  •  ...About the job Regulatory Affairs Specialist Regulatory Affairs Specialist requires: ~1-3 years experience in regulatory affairs field of Laundry and detergents or CPG products. ~ Knowledge of federal and state statutes and regulations related to pesticide... 
    Work at office
    Local area

    Global Channel Management

    Trumbull, CT
    4 hours ago
  •  ...Regulatory Affairs Specialist The following skills and abilities are directly related to the essential functions of the job. High School diploma or equivalent, Associate degree preferred. Strong high-end PC skills and word processing/editorial skills Sound... 
    Worldwide
    Day shift

    Saviance

    Indianapolis, IN
    3 days ago
  • $74.4k - $111.6k

     ...of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory Affairs team. The selected candidate will provide regulatory support on a range... 
    H1b
    Work at office
    Local area
    Flexible hours

    Medtronic

    North Haven, CT
    2 days ago
  •  ...Responsible for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs Director with regulatory strategy/plans and requirements. Prepares worldwide regulatory... 
    Casual work
    Immediate start
    Worldwide

    Atrium Medical

    Hudson, NH
    3 days ago
  •  ...Regulatory Affairs Specialist We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact on the... 
    Worldwide
    Flexible hours

    Laborie Medical Technologies

    Minnetonka, MN
    4 hours ago
  •  ...Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish... 
    Contract work
    Work at office

    Merck & Co. Inc

    Warsaw, IN
    5 hours ago
  •  ...radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology. The Regulatory Affairs Specialist / Regulatory Affairs Specialist II / Senior Regulatory Affairs Specialist is primarily responsible for assisting... 
    Contract work
    Interim role
    Flexible hours

    Imperatrix Datum Solutions Corporation

    Scottsdale, AZ
    3 days ago
  •  ...What You’ll Do The Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related to product submissions and approvals. In this role, you will prepare and submit regulatory documentation, support product market approval and... 
    Full time
    Immediate start

    Anika Corporation

    Bedford, MA
    4 days ago
  •  ...US Regulatory Affairs Lead Scope of Responsibilities: He/She will be responsible for representing regulatory function to approve promotional material. He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making... 

    Aequor Inc

    San Diego, CA
    2 days ago
  • $78k - $100k

    Inside the Role As an Import Entry Review Analyst II, you will play a key role in supporting DTNA's import compliance program by helping ensure customs entry information is accurate, complete, and compliant before filing deadlines. Working closely with customs brokers...
    Temporary work
    For contractors
    Work at office
    Local area
    Remote work
    Relocation
    Relocation package

    Daimler Truck North America

    Portland, OR
    3 days ago
  •  ...GloFish®, DreamBone® and SmartBones®. Job Summary Join a team that helps bring innovative products to market while ensuring they meet regulatory requirements worldwide. In this role, you'll support new product development, safety data sheet maintenance and authoring, and... 
    Work at office
    Worldwide

    Spectrum Brands

    Saint Louis, MO
    4 days ago
  • $63k - $95k

    ## Regulatory Affairs SpecialistApplylocations: Oak Brooktime type: Full timeposted on: Posted Yesterdayjob requisition id: R-2026-692The name...  ...the top 10 pharmaceutical companies.The Regulatory Affairs Specialist supports the regulatory strategy, prepares and maintains... 
    Immediate start
    Worldwide
    Flexible hours

    Sotera Health LLC

    Oak Brook, IL
    4 days ago
  •  ...All Jobs Regulatory Affairs Specialist Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and... 

    PreludeDx

    Laguna Woods, CA
    1 day ago
  • $74.4k - $111.6k

     ...healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory Affairs team. The selected candidate will provide regulatory support on a... 
    Full time
    H1b
    Work at office
    Local area
    Immediate start
    Flexible hours

    Medtronic

    North Haven, CT
    14 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!