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Senior Regulatory Affairs SME

Senior Regulatory Affairs SME

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Senior Regulatory Affairs SME

  • Location:

    Buckinghamshire

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Permanent - full time

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    GGFMDD_1721665221

  • Published:

    11 months ago

  • Startdate:

    ASAP

Are you an expert in Regulatory strategies with a passion for medical devices? We are seeking a Senior Regulatory Affairs Specialist to lead and develop regulatory strategies across the EMEA region and globally. The role is Hybrid and will working in the Berkshire / Bucks area.


Key Responsibilities:

  • Coordinate Regulatory Deliverables: Manage regulatory deliverables for medical devices to ensure compliance and timely approvals.
  • Develop Partnerships: Collaborate with R&D, Marketing, and local regulatory teams to align on regulatory strategies and objectives.
  • Prepare and Maintain Technical Files: Compile and update technical files and submission packages to meet regulatory requirements.
  • Represent Regulatory Affairs: Act as the Regulatory Affairs representative within the franchise, providing insights and guidance on regulatory matters.


Requirements:

  • Educational Background: Relevant Bachelor's Degree or higher in a related field.
  • Medical Device Expertise: In-depth knowledge and experience with Class I-III Medical Devices.
  • Regulatory Knowledge: Strong understanding of Medical Device Directive (MDD), Medical Device Regulation (MDR), and ISO 13485 standards.
  • OTC or Consumer Health experience would be an added bonus.
  • Language Proficiency: Fluency in English, both written and spoken.
  • Experience with Notified Bodies: Proven experience working with Notified Bodies and understanding of regulatory frameworks.


Why Join Us?

  • Critical Role in Product Lifecycle Management: Play a pivotal role in managing the lifecycle of our products, from development to market.
  • Influence Regulatory Strategies: Have a significant impact on the development and execution of regulatory strategies and outcomes.
  • Collaborative Environment: Work with a dynamic, cross-functional team dedicated to innovation and excellence in regulatory affairs.

Apply now to be part of an innovative team driving regulatory excellence and compliance

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