Regulatory Affairs Specialist, IVD Compliance Expert

3 weeks ago


Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

Role Overview:

We are seeking a highly skilled Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This individual will play a key role in coordinating and tracking International submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent's extensive IVD portfolio.

Key Responsibilities:

  • Support IVDR regulatory activities, including design history file review, IVDR strategy drafting, and Requirements documentation preparation
  • Implement tools for accurate tracking of product changes
  • Collaborate with Global Regulatory Affairs ensuring regulatory assessments of changes are sought, obtained, and documented
  • Collaborate with project team representatives for accurate tracking on project deliverables
  • Oversight of IVD registrations and renewals
  • Ensure timely registration of IVD products and their renewals

Requirements:

  • A university degree in a relevant field such as Life-Science/Engineering/Law etc.
  • Significant regulatory experience with a solid understanding of IVD/medical device regulations and registration requirements
  • Ability to interpret regulations and standards in relation to specific products
  • Excellent interpersonal and communication skills in English

What We Offer:

  • An independent job in collaboration with good colleagues, in a growth-oriented organization
  • A true commitment to work/life balance
  • An opportunity to learn and grow in the field of Regulatory Affairs
  • A competitive salary of approximately $85,000 per year, plus benefits, stock purchase plan, life insurance, pension, healthcare, employee assistance program, holiday, company activities


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