Principal Regulatory Affairs Strategist

Found in: beBee jobs US - 2 weeks ago

Deer Park, Texas, United States Danaher Full time

Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.

Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

This role is eligible for a remote work arrangement.

The Principal Regulatory Affairs Strategist has responsibilities for regulatory strategy development and execution for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology environment. You will provide oversight and lead 510k and PMA submission work and will mentor the RA organization in these key activities. The role collaborates cross-functionally and, with internal and external business partners on new product development and strategic initiatives to lead the regulatory activities for global commercialization with focus on the US market clearance. The incumbent has the ability to innovate, communicate and execute strategic regulatory plans, drive results independently and in a matrix-team environment and is willing to solve complex problems to meet business obligations on-time.

Major Responsibilities

  • Serve as regulatory lead for business-critical new product development projects and external partnership programs; including oversight for product lifecycle management ensuring that the state of the art requirements are maintained
  • Work with regulatory agencies to establish least burdensome regulatory strategies/paths to validate desired product claims for LBS products, including 510(k), PMA and companion diagnostic submissions
  • Manage schedules for regulatory submissions (for example, 510(k), PMA, preSUBs, etc.), coordinate the preparation and staging of all regulatory documentation, and actively monitor and track submissions under review
  • Lead regulatory agency interactions for products under review, ensure timely responses and communications, and successfully navigate through the process to secure registrations
  • Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to 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.
  • Maintain regulatory intelligence on US and International regulatory requirements and proactively manage impact to LBS current and future portfolio
  • Actively participate in project core team meetings and drive to collaboratively achieve project goals and meet timelines
  • Critically review and approve analytical and clinical study protocols and reports to assess quality, to identify gaps, and provide mitigations
  • Provide periodic updates on status of projects to larger cross-functional audience and leadership
  • Ensure compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect
  • Mentor and coach LBS Regulatory professionals in their development
  • Integrates DBS principles and practices including leading continuous improvement initiatives, solving complex problems and driving for measurable results.

Required Skills/Experience/Education

  • Bachelor, Master or PhD degree in science or engineering with 8 years Regulatory experience in the IVD industry
  • Expert in FDA and EU regulations for IVDs and/or medical devices
  • Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials
  • Proven experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA
  • Experience in the IVD, Companion Diagnostics and/or stand-alone software/digital fields preferred.
  • Strong inter-personal skills and an ability to effectively communicate complex ideas and concepts to a diverse audience

Travel expectations for this role are

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