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Danaher Corporation Senior Regulatory Affairs Specialist in York, United Kingdom

ESSENTIAL JOB RESPONSIBILITIES:

  • Support the IVDR transition project

  • Lead up to two IVDR conversion subteams for specific Genexpert assays and class A devices as prioritized

  • Closely collaborate with other functions to achieve the goal in the set timelines

  • Review project documentation, performance evaluation protocols and reports and evaluates whether regulatory product requirements and guidelines are met and suitable for submission to external parties

  • Compile and update of Technical Files/Technical Documentation

  • Compile and make files ready for publishing and submission

TRAINING RESPONSIBILITIES: (REQUIRED)

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level

  • A minimum of 5-7 years of experience in Regulatory Affairs within IVD or Medical Device industry

  • Experience representing Regulatory Affairs within project development and change projects

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.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.If you’ve ever wondered what’s within you, there’s no better time to find out.

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