Technology Consultant - Regulatory Submissions Jobs | Glassdoor
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Technology Consultant - Regulatory Submissions Jobs

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  • 3.6
    Foundation Medicine – United States
    Est. Salary $56k-$83k
    15 days ago 15d
    Experience with regulatorysubmissions [PMA, IDE, 510(k)] with a manufacturer or in a regulatoryconsulting role PhD preferred… assist with Regulatory Affairs activities by writing and editing technical documentation to be included in submissions to the FDA…
  • 3.1
    TSR Consulting – Princeton, NJ
    6 days ago 6d
    preparation and submission of global regulatory dossiers Utilize regulatory experience to determine submission content and execution… in building submissions for publishing Ensure dossiers and documentation meet electronic regulatorysubmission requirements…
  • 3.5
    EMD Serono – Billerica, MA
    NEW
    5 years of global regulatory experience. Experience in preparation and management of IND/CTA submissions for FIM Prior experience… TIPs Initiate regulatory plans regarding novel technology/methodology Qualification Responsible for regulatory activities related…
  • 3.6
    AbbVie – Waukegan, IL
    NEW
    strategic regulatorysubmission documents comprised of high-quality, scientific justification, and relevant regulatory style/reference… publications or clinical regulatory document preparation and submissions Experience writing regulatory documents in multiple therapeutic…
  • 4.1
    Alpha Consulting – Wilmington, DE
    15 days ago 15d
    prompt submission of expedited reports, including preparing cross reporting submissions, to the RegulatorySubmissions Department… Description: Provides accurate and timely US regulatorysubmissions preparation and submission of reports meeting US FDA expedited reporting…
  • 5.0
    JobJuncture – Framingham, MA
    Est. Salary $77k-$133k
    NEW
    valid regulatorysubmissions in various geographic jurisdictions. This individual is also responsible for all regulatory maintenance… interact with domestic and international regulatory authority personnel, consultants and vendors at appropriate stages of development…
  • 2.5
    Mallinckrodt Pharmaceuticals – Saint Louis, MO
    Today 10hr
    administration of regulatory systems in support of Specialty Generics publishing and submission and pre-submission work. The person… System Adminstrator, Regulatory Operations Requisition JR000007483 System Adminstrator, Regulatory Operations (Open)…
  • 4.4
    Beacon Hill Staffing Group – Cambridge, MA
    EASY APPLY
    10 days ago 10d
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manage regulatorysubmissions and author… compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatorysubmission plan. Sets…
  • 3.8
    Veeva Systems – United States
    4 days ago 4d
    customers transform the way they manage their regulatory information, submission content and archives in the cloud. As a key member… FirstDoc/FirstPoint, NextDocs, CARA, other regulatory information management or submission publishing systems, etc. Life Science,…
  • 3.5
    Relypsa, Inc. – Redwood City, CA
    Est. Salary $139k-$184k
    Today 7hr
    Create and maintain regulatory timelines and track deliverables to timelines to ensure that regulatorysubmission timelines are met… Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatorysubmissions. Requirements…
  • 4.4
    Beacon Hill Staffing Group – Boston, MA
    EASY APPLY
    NEW
    side prior to entering regulatory affairs Strong Project Management Skills Experience with submissions, complaints, MDRs Flexible… complaints, MDRs, etc. Assist with submissions - Supplemental submissions, 510k submissions Potentially assist with international…
  • 3.6
    Silicus Technologies – Houston, TX
    Est. Salary $45k-$69k
    NEW
    and consulting services to several Fortune 1000 companies. We are looking for an experienced Regulatory Affairs Consultant to join… in medical devices. Background and experience with regulatoryconsulting in the medical devices area. Experience with medical…
  • 3.6
    Edwards Lifesciences – Irvine, CA
    Est. Salary $115k-$171k
    NEW
    execute clear regulatory plans. The role requires strategic planning, preparation and management of regulatorysubmissions for US, EU… US FDA, Notified Bodies, in-country regulatory representatives, distributors, consultants, etc.) Review and approve design,…
  • 3.1
    Medline Industries – Northfield, IL
    Est. Salary $50k-$73k
    9 days ago 9d
    international regulatory affairs as it relates to medical device product development and various international submissions, research… product development teams and the preparation and submission of regulatory documentation for product registration/licensing in…
  • 2.6
    LSNE Contract Manufacturing – Bedford, NH
    EASY APPLY
    Est. Salary $70k-$103k
    NEW
    technical reports, technology transfer packages and presentations Contributes to regulatorysubmissions. Develop project scopes… enabling studies and contributions to the preparation of regulatorysubmissions. The feasibility studies include small and pilot scale…
  • 3.5
    Wells Fargo – North Brunswick, NJ
    Est. Salary $100k-$152k
    5 days ago 5d
    clarity on regulatory reporting issues, troubleshoot reporting issues and delayed submissions to provide clarity on regulatory reporting… Brunswick, NJ. Regulatory Reporting Technology team supports the global transaction regulatory reporting requirements of Capital Markets…
  • 3.5
    Navigant – Boston, MA
    Est. Salary $72k-$100k
    Today 8hr
    services to companies from quality/regulatory strategies through product development submission, commercialization, post market surveillance… Products, & Health Information Technologies, all of which require unique U.S. and global, regulatory & quality, industry knowledge…
  • 3.8
    Veeva Systems – United States
    23 days ago 23d
    NextDocs, CARA, other regulatory information management or submission publishing systems, etc. Consulting experience Life Science… Registrations, Vault Submissions, Vault Submissions Archive) which is used to manage regulatory affairs and regulatory operations content…
  • 4.0
    Johnson & Johnson – Raritan, NJ
    Est. Salary $147k-$210k
    5 days ago 5d
    for Enterprise Regulatory Operations is a strong leader who can combine consulting, modern Information Technology (IT) expertise… information and technology initiatives that modernize workflow, analytics, regulatory intelligence and regulatory operations capabilities…
  • 3.2
    Verathon – Bothell, WA
    Est. Salary $87k-$130k
    23 days ago 23d
    team of Regulatory Associates and as required, contracted clinical study, medical professionals or other consultants to achieve… Senior Manager Regulatory Affairs Location Bothell, WA, USA (HQ) Department Quality Assurance & Regulatory Affairs…
  • 4.0
    Eli Lilly – Indianapolis, IN
    Today 5hr
    Central Designer, Clintrial Integrations and CTMM Integrations, Submissions, Integrated Databases, MedDRA/WhoDRUG/SAE in InForm/LSS and… representation principles Knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc…
  • 3.2
    Inventiv Health Clinical – San Francisco, CA
    Est. Salary $114k-$158k
    NEW
    maintain reporting dashboards for teams and management. Track submission preparation progress, including but not limited to post-marketing… Job Description Job Description: A Regulatory Project Manager is needed for a contract position at major pharma company in Northern…
  • 3.6
    NantWorks – Culver City, CA
    Est. Salary $78k-$114k
    24 days ago 24d
    Plans and prepares regulatorysubmissions (510(k), PMA, Technical Files and other regulatory documentation) for product… requisite pre-submissions and post-market approval reports with moderate supervision. Ensures regulatorysubmissions are prepared…
  • 3.8
    Cutera – Brisbane, CA
    Est. Salary $80k-$113k
    6 days ago 6d
    scientifically valid submissions Author sections of regulatorysubmissions, as appropriate Provide regulatory strategy input to… Responsibilities: Collaborate in the preparation of regulatorysubmissions, clearances, and approvals within the US and for direct…
  • 4.0
    Fred Hutchinson Cancer Research Center – Seattle, WA
    Est. Salary $57k-$84k
    NEW
    and Scientific Review Committee. Oversees timely regulatorysubmissions to meet institutional, NCI NCTN and other relevant project… as a regulatoryconsultant at process improvement workgroups, institutional meetings, and conferences Provide regulatory support…
  • 3.8
    Singulex – Alameda, CA
    Est. Salary $125k-$208k
    6 days ago 6d
    requiring regulatory agency approval, as pertains to US and international regulatory requirements. Manage submission activities… requirements. Hires and works with external consultants as needed to achieve regulatory aspects of the business goals PERSONAL…
  • 4.5
    EXTEDO GmbH – Wayne, PA
    28 days ago 28d
    seeking a Publishing Consultant, Regulatory Operations Your Tasks - as important as our Software: Publish submissions (new applications… enabling technology, the EXTEDOsuite, is unique in all that it covers within Regulatory Affairs including: eCTD submission management…
  • Basking Ridge, NJ
    6 days ago 6d
    Responsible for regulatorysubmission process improvements and establishing repeatable processes utilizing key technologies Strategy… planning, publishing, production, dispatch, and archive of regulatorysubmissions and supports a specific subset of a discipline within…
  • 2.9
    State of Florida – Tampa, FL
    Est. Salary $46k-$79k
    Today 11hr
    Preference must attach supporting documentation with each submission that includes character of service (for example, DD Form 214… Print Reading. With Federal Housing and/or a Government Regulatory program Filing, organizing and/or maintaining records.…
  • 2.9
    Daiichi Sankyo – Basking Ridge, NJ
    Est. Salary $87k-$149k
    5 days ago 5d
    Responsible for regulatorysubmission process improvements and establishing repeatable processes utilizing key technologies Strategy… planning, publishing, production, dispatch, and archive of regulatorysubmissions and supports a specific subset of a discipline within…
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