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R&D Manager - Process Development Office

Job Description


Are you interested to join a team with the mission to fight cancer?


We are seeking a strong leader to manage our R&D Process Development Office team responsible for the product development and design processes for cancer diagnostic products in the Agilent Pathology Division.

In this role you will own the product development process for instrument, software, and reagent devices in the Pathology Division as well as our sister divisions Companion Diagnostics and Reagent Partnerships. Furthermore, you will be building and expanding your network and influence by leading increased alignment of development processes with the Agilent Enterprise system. You will have the ability to lead major initiatives to continuously improve our product development and maintenance processes with focus on compliance, effectiveness, efficiency, and quality. Success in the role involves global alignment and engagement with stakeholders within and outside the Pathology Division to secure strong processes for regulatory design controls critical in the context of in vitro diagnostics (IVD). The Process Development Office team is based in Glostrup, Denmark and consists of 4 people.

The team responsibilities include:

  • Ownership of the QMS product development and design control processes.
  • Assuring ongoing compliance of the product development processes, including alignment with related QMS processes.
  • Leading and facilitating continuous improvement of product development process efficiency without compromising compliance with regulatory requirements for IVD medical devices.
  • Collaborating closely with colleagues across the organizations including R&D, Product Marketing, Manufacturing, and RA/QA.
  • Your responsibilities include:

  • Overseeing product development and design processes with a proactive mindset to continuously seek input from regulatory requirements and stakeholders.
  • Identifying and prioritizing process improvement opportunities.
  • Leading and developing the Process Development Office team members.
  • Building and maintaining alliances with Agilent counterparts across teams and locations.
  • Creating and implementing long-term strategic plans.
  • Leading high visibility, high impact change initiatives.
  • Working according to the financial framework.

  • Qualifications


    Your qualifications:

  • Background within natural science, engineering or similar and 5+ years of experience with product development.
  • 5+ years of experience with design control within Medical devices or IVD.
  • Solid knowledge of ISO13485 and FDA CFR 21 Part 820.
  • Strong change management skills with proven track record in leading the definition and implementation of changes.
  • High desire and capability to build your network.
  • Proven ability to lead global initiatives.
  • 3+ years of people management experience.
  • Proficiency in written and spoken English.

  • You are expected to be based in Glostrup, Denmark.

    You report directly to Head of R&D of the Pathology Division and are a member of the R&D Management team.

    Ques tions:
    If you have any questions to the position


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