Senior Principal Specialist, Quality Assurance - Newcastle upon Tyne, United Kingdom - Leica Biosystems

Leica Biosystems
Leica Biosystems
Verified Company
Newcastle upon Tyne, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description
In this role, you will have the opportunity to:

  • Serve as Quality Assurance lead for Design Control covering business-critical new product development projects and external partnership programs, including ensuring that state-of-the-art requirements are maintained throughout the product lifecycle.
  • Collaborate globally and crossfunctionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines.
  • Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations that support successful new product development, bringing highquality product to market.
  • Define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD, and Companion Diagnostics markets, including providing input into 510(k), PMA and companion diagnostic submissions and acting on regulatory intelligence changes to ensure mínimal impact to current and future portfolio.
  • Mentor and coach LBS Quality Assurance professionals in their development and support building team capabilities.

The essential requirements of the job include:

  • Extensive experience in medical device industry covering Innovation and Design Control.
  • Proven experience supporting submissions for highcomplexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA.
  • Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, and the MDSAP programme.
  • Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization.
  • Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials and Pharma partner integration.
It would be a plus if you also possess previous experience in:

  • The IVD, Companion Diagnostics, and/or stand-alone software/digital fields.
  • Collaborating with external stakeholders, such as suppliers, and academia.
  • FDA and EU requirements covering Design Control activities for IVDs and/or medical devices.
At Leica Biosystems we believe in designing a better, more sustainable workforce.

We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.

This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home.

Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.


At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.

Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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