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Senior Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Boston
Posted on: November 26, 2022

Job Description:

Responsibilities:


  • The new RA position is dedicated to the Reusable Pen Platform, Pen and Pen needles registered in over 80 countries.
  • Drive Global implementation and customer deliverables for Reusable Pen platform per PS RA team Strategy
  • Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
  • Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
  • Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers)
  • Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
  • Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders

    Requirements:


    • B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred.
    • Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
    • Medical device and international registration experience is a must. Combination Products knowledge or experience is a plus.
    • Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
    • Strong project management and communication (verbal, written) and skills
    • Able to independently handle multiple tasks/projects with minimum supervision
    • Self-starter with the ability to take over responsibilities
    • Team player, Attention to details, highly result-oriented
    • Flexible and reliable personality; ability to manage stressful situations
    • High personal integrity and ethical standards
    • Ability to drive and maintain favorable customer experience and customer-centricity (internal & external Related work experience in medical device regulatory field (regulatory submissions, compliance, project management medical device and international registration experience is a must.
    • Combination Products knowledge or experience is a plus Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive.
    • Share Point Strong project management and communication (verbal, written) and skills able to independently handle multiple tasks/projects with minimum supervision

Keywords: Katalyst Healthcares & Life Sciences, Boston , Senior Regulatory Affairs Specialist, Other , Boston, Massachusetts

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