Senior Principal Specialist, Quality Assurance (Design)

You will be a part of the Newcastle Leadership Quality Assurance and Regulatory Compliance team and report to the Director, Quality Assurance and Regulatory Compliance. You will be responsible for applying in-depth knowledge, experience, expertise in multiple areas of medical device quality assurance, guiding the Quality Assurance design organisation in key Design Control activities, and collaborating cross-functionally with internal and external business partners on new product development and strategic initiatives to drive project results.

If you thrive in a fast paced, multifunctional role and want to work to build a world-class Quality Assurance organization, read on.

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 cross-functionally (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 high-quality 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 minimal 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 high-complexity 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.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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.