• Job Description

  Req#: 14E2A63AE3634008BFDA024FB7CC2719
  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.
  
  The Staff Regulatory Affairs Specialist for Leica Biosystems is responsible for regulatory strategy development and execution for high-complexity diagnostics including but not limited to IVDs and Companion Diagnostics in the clinical oncology environment. You will collaborate cross-functionally and with internal and external business partners on new product development and strategic initiatives to lead the regulatory activities for global commercialization. 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.
  
  This position is part of the Global Regulatory Affairs organization and will be fully remote in the USA. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
  
  Major Responsibilities
  
  • Serve as Regulatory Affairs representative on new product development teams and external partnership programs.
  • Collaborate globally and cross-functionally (e.g., Global 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.
  • Provide regulatory input to support program scoping including resource requirements and timeline.
  • Define and progress evidentiary requirements to meet targeted commercial claims and align with internal partners and stakeholders on study designs.
  • Align with external partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
  • Author and maintain regulatory submissions including defining the global regulatory requirements, creating standard work and action plans, optimizing timelines, articulating submission content and format and developing countermeasures as plans evolve.
  • Communicate and negotiate with global regulatory agencies to meet business goals and regulatory milestones for product commercialization.
  • Keep informed of new and evolving regulatory intelligence and maintain working knowledge of relevant regulations, guidance, requirements and competitive products that affect the business; provide interpretation and education to internal and external stakeholders.
  • Share information and experience across LBS and Danaher sites; serves as representative on taskforces, councils or improvement initiatives.
  • Integrate DBS principles and practices including leading continuous improvement initiatives, solving complex problems and driving for measurable results.
  • Other duties as assigned by management.
  
  Required Skills/Experience/Education
  
  • Bachelor's degree in science or engineering or equivalent experience.
  • Must have requisite training in IVD or medical device Regulatory Affairs through on-the-job training, seminars or certification. Experience in the IVD, Companion Diagnostics fields strongly preferred.
  • Proven experience (5+ years) with regulatory strategy and cleared/approved submissions for high-complexity diagnostic products in a global market, such as 510(k)s or PMAs in the USA and IVDR in Europe
  • Progressive experience in support of New Product Development for high complexity products. Experience supporting clinical trials a plus.
  
  Travel %
  
  • Travel expectations for this role are
  
  Location:
  
  • This is a Remote Position supporting LBS Newcastle UK and Danvers, MA, USA. Candidate must be flexible to work across time zones.
  
  Reporting to:
  
  • Director, Global Regulatory Affairs
  
  At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.
  
  The salary range for this role is $115,000 - $130,000 . This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
  
  This job is also eligible for bonus/incentive pay.
  
  We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
  
  Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
  
  #LI-REMOTE
  
  When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
  
  Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

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